Viewing Study NCT01691768

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Ignite Creation Date: 2025-12-24 @ 5:38 PM
Ignite Modification Date: 2026-02-22 @ 4:50 PM
Study NCT ID: NCT01691768
Status: COMPLETED
Last Update Posted: 2019-11-26
First Post: 2012-07-05
Is Gene Therapy: True
Has Adverse Events: True
Brief Title: Implementation Effectiveness and Safety of Tenofovir Gel Provision Through Family Planning Services
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'nonhlanhla.yende@caprisa.org', 'phone': '+27 31 260 4392', 'title': 'Nonhlanhla Yende-Zuma', 'organization': 'CAPRISA'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The 2-3 monthly intervals between clinic appointments in the control arm is likely to introduce recall bias in this arm, unlike the monthly intervals in the intervention arm.'}}, 'adverseEventsModule': {'timeFrame': 'Between 2012 and 2015, up to 28 months.', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention', 'description': '1% tenofovir gel provision through a public sector family planning services with 2-3 monthly provision and monitoring and the use of QI methodology to promote reliable service delivery\n\n1% tenofovir gel: Participants will be randomized to receive 1% tenofovir gel through either:\n\n* Public sector family planning services with 2-3 monthly provision and monitoring of 1% tenofovir gel and the use of QI methodology to promote reliable service delivery (intervention arm), or\n* The CAPRISA research clinics with monthly provision and monitoring of 1% tenofovir gel (control arm).', 'otherNumAtRisk': 189, 'deathsNumAtRisk': 189, 'otherNumAffected': 166, 'seriousNumAtRisk': 189, 'deathsNumAffected': 0, 'seriousNumAffected': 13}, {'id': 'EG001', 'title': 'Control', 'description': 'monthly 1% tenofovir gel provision and monitoring through CAPRISA research clinics\n\n1% tenofovir gel: Participants will be randomized to receive 1% tenofovir gel through either:\n\n* Public sector family planning services with 2-3 monthly provision and monitoring of 1% tenofovir gel and the use of QI methodology to promote reliable service delivery (intervention arm), or\n* The CAPRISA research clinics with monthly provision and monitoring of 1% tenofovir gel (control arm).', 'otherNumAtRisk': 183, 'deathsNumAtRisk': 183, 'otherNumAffected': 181, 'seriousNumAtRisk': 183, 'deathsNumAffected': 2, 'seriousNumAffected': 17}], 'otherEvents': [{'term': 'Conjunctivitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 17, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 19, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numEvents': 22, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 60, 'numAffected': 45}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Body tinea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numEvents': 15, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 18, 'numAffected': 17}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numEvents': 20, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 22, 'numAffected': 18}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numEvents': 27, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 112, 'numAffected': 66}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pelvic inflammatory disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 19, 'numAffected': 16}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numEvents': 22, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 31, 'numAffected': 25}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numEvents': 36, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 34, 'numAffected': 24}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 20, 'numAffected': 17}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Vaginitis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Vulvovaginitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numEvents': 29, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 49, 'numAffected': 39}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Blood pressure diastolic increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numEvents': 50, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 31, 'numAffected': 27}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numEvents': 26, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 13, 'numAffected': 11}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Blood pressure systolic increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numEvents': 53, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 27, 'numAffected': 20}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Abnormal loss of weight', 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 13, 'numAffected': 10}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 25, 'numAffected': 21}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 19, 'numAffected': 19}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numEvents': 30, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 91, 'numAffected': 62}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Genital ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 16, 'numAffected': 15}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Vaginal discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numEvents': 91, 'numAffected': 67}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 102, 'numAffected': 73}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 33, 'numAffected': 26}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numEvents': 18, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 14, 'numAffected': 11}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}], 'seriousEvents': [{'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Anal sphincter atony', 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': "Crohn's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Acute sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Oesophageal candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Post procedural sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Postoperative wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hand fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Investigation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Diabetic ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Soft tissue mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Ameloblastoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Complication of pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Gestational hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pre-eclampsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Premature labour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Ruptured ectopic pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Completed suicide', 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Schizoaffective disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Calculus ureteric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Neurogenic bladder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Anoplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Caesarean section', 'stats': [{'groupId': 'EG000', 'numAtRisk': 189, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Number of Returned Used Applicators Per Month (i.e in 30 Days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': '1% tenofovir gel provision through a public sector family planning services with 2-3 monthly provision and monitoring and the use of QI methodology to promote reliable service delivery\n\n1% tenofovir gel: Participants will be randomized to receive 1% tenofovir gel through either:\n\n* Public sector family planning services with 2-3 monthly provision and monitoring of 1% tenofovir gel and the use of QI methodology to promote reliable service delivery (intervention arm), or\n* The CAPRISA research clinics with monthly provision and monitoring of 1% tenofovir gel (control arm).'}, {'id': 'OG001', 'title': 'Control', 'description': 'monthly 1% tenofovir gel provision and monitoring through CAPRISA research clinics\n\n1% tenofovir gel: Participants will be randomized to receive 1% tenofovir gel through either:\n\n* Public sector family planning services with 2-3 monthly provision and monitoring of 1% tenofovir gel and the use of QI methodology to promote reliable service delivery (intervention arm), or\n* The CAPRISA research clinics with monthly provision and monitoring of 1% tenofovir gel (control arm).'}], 'classes': [{'title': 'Intent to treat analyses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.2', 'groupId': 'OG000', 'lowerLimit': '4.7', 'upperLimit': '5.7'}, {'value': '5.7', 'groupId': 'OG001', 'lowerLimit': '5.2', 'upperLimit': '6.2'}]}]}, {'title': 'Per protocol analyses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}, {'value': '175', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.5', 'groupId': 'OG000', 'lowerLimit': '5.0', 'upperLimit': '6.1'}, {'value': '5.8', 'groupId': 'OG001', 'lowerLimit': '5.3', 'upperLimit': '6.3'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.47', 'ciLowerLimit': '-1.16', 'ciUpperLimit': '0.21', 'estimateComment': 'The least square mean from the intervention arm was the minuend and the least square mean from the control arm was the subtrahend.', 'groupDescription': 'Intent to treat population (all participants who were randomized, met pre-randomization eligibility criteria and who have post-enrollment follow-up data) was used for this analyses.', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'Univariate Linear Mixed Models were used to analyze primary outcome.', 'nonInferiorityComment': 'We estimated that we would need to enrol 700 women after taking into account the anticipated loss-to follow-up in order to provide 90% power to demonstrate whether gel use in women attending family planning (intervention) services is similar to, but no more than 20% lower than, gel use among women attending CAPRISA research clinics (control).', 'otherAnalysisDescription': 'The primary endpoint was compared using univariate linear mixed model with compound symmetry structure.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.25', 'ciLowerLimit': '-0.98', 'ciUpperLimit': '0.48', 'estimateComment': 'We calculated the difference in means between the two arms. The mean from the intervention arm was the minuend and the mean from the control arm was the subtrahend.', 'groupDescription': 'This is the analyses from the per protocol population (excluding all subsequent data collected from participants who were not dispensed product for more than 120 days).', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'Univariable Linear Mixed Models was used for the analyses', 'nonInferiorityComment': 'We estimated that we would need to enrol 700 women after taking into account the anticipated loss-to follow-up in order to provide 90% power to demonstrate whether gel use in women attending family planning (intervention) services is similar to, but no more than 20% lower than, gel use among women attending CAPRISA research clinics (control)'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Between 2012 to 2015, up to 28 months', 'description': 'The primary endpoint is the mean number of returned used applicators per month. Since participants in the intervention arm followed two and three monthly schedule (as opposed to monthly in the intervention arm), the number of returned used applicators per month for each participant will be estimated as the total number of returned applicators at that visit divided by the number of days since the previous visit, multiplied by 30. Thus a uniform distribution of gel use will be assumed in participants whom we did not see monthly. Intent to treat and per protocol analyses were carried out of this outcome. Intent to treat population includes all participants who were randomized, met pre-randomization eligibility criteria and who have post-enrollment follow-up data. The per protocol population is a subset of the intent to treat population.The per-protocol analysis excluded visits where no gel had been dispensed for \\>120 days.', 'unitOfMeasure': 'Used gel applicators per month', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat population and the per protocol population (excluding all subsequent data collected from participants who were not dispensed product for more than 120 days).'}, {'type': 'SECONDARY', 'title': 'HIV Incidence Rates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': '1% tenofovir gel provision through a public sector family planning services with 2-3 monthly provision and monitoring and the use of Quality Improvement methodology to promote reliable service delivery\n\n1% tenofovir gel: Participants will be randomized to receive 1% tenofovir gel through either:\n\n* Public sector family planning services with 2-3 monthly provision and monitoring of 1% tenofovir gel and the use of Quality Improvement methodology to promote reliable service delivery (intervention arm), or\n* The CAPRISA research clinics with monthly provision and monitoring of 1% tenofovir gel (control arm).'}, {'id': 'OG001', 'title': 'Control', 'description': 'monthly 1% tenofovir gel provision and monitoring through CAPRISA research clinics\n\n1% tenofovir gel: Participants will be randomized to receive 1% tenofovir gel through either:\n\n* Public sector family planning services with 2-3 monthly provision and monitoring of 1% tenofovir gel and the use of QI methodology to promote reliable service delivery (intervention arm), or\n* The CAPRISA research clinics with monthly provision and monitoring of 1% tenofovir gel (control arm).'}], 'classes': [{'categories': [{'measurements': [{'value': '3.5', 'groupId': 'OG000', 'lowerLimit': '1.8', 'upperLimit': '6.0'}, {'value': '3.6', 'groupId': 'OG001', 'lowerLimit': '1.9', 'upperLimit': '6.3'}]}]}], 'analyses': [{'pValue': '0.928', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Incidence rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.96', 'ciLowerLimit': '0.40', 'ciUpperLimit': '2.35', 'estimateComment': 'We calculated incidence rate ratio, where the HIV incidence rate for the intervention arm represents the numerator and the HIV incidence rate for the control arm represents the denominator.', 'groupDescription': 'The power was not calculated for all the secondary outcomes.', 'statisticalMethod': 'z-test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'We used z-test to compare incidence rates between the arms. We did not use log-rank test because we did not present survival curves.'}], 'paramType': 'NUMBER', 'timeFrame': 'Between 2012 and 2015, up to 28 months', 'description': 'Time to HIV infection was calculated as the difference between estimated date of infection (midpoint between the last negative HIV test date and the first confirmed positive HIV test date) and enrolment date, plus one. Where a participant has a positive PCR and a negative rapid test on the same date, the date of infection is calculated as 14 days prior to this date. Women who do not become HIV positive before their last study visit will be censored on the day of their last negative HIV test. Their follow-up time will be calculated as the difference between date of censoring and enrolment date, plus one.', 'unitOfMeasure': 'Incidence rate/100 women years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat population(all participants who were randomized, met pre-randomization eligibility criteria and who have post-enrollment follow-up data).'}, {'type': 'SECONDARY', 'title': 'Pregnancy Incidence Rates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': '1% tenofovir gel provision through a public sector family planning services with 2-3 monthly provision and monitoring and the use of Quality Improvement methodology to promote reliable service delivery\n\n1% tenofovir gel: Participants will be randomized to receive 1% tenofovir gel through either:\n\n* Public sector family planning services with 2-3 monthly provision and monitoring of 1% tenofovir gel and the use of Quality Improvement methodology to promote reliable service delivery (intervention arm), or\n* The CAPRISA research clinics with monthly provision and monitoring of 1% tenofovir gel (control arm).'}, {'id': 'OG001', 'title': 'Control', 'description': 'monthly 1% tenofovir gel provision and monitoring through CAPRISA research clinics\n\n1% tenofovir gel: Participants will be randomized to receive 1% tenofovir gel through either:\n\n* Public sector family planning services with 2-3 monthly provision and monitoring of 1% tenofovir gel and the use of QI methodology to promote reliable service delivery (intervention arm), or\n* The CAPRISA research clinics with monthly provision and monitoring of 1% tenofovir gel (control arm).'}], 'classes': [{'categories': [{'measurements': [{'value': '4.9', 'groupId': 'OG000', 'lowerLimit': '2.8', 'upperLimit': '7.9'}, {'value': '5.1', 'groupId': 'OG001', 'lowerLimit': '2.9', 'upperLimit': '8.3'}]}]}], 'analyses': [{'pValue': '0.895', 'groupIds': ['OG000', 'OG001'], 'paramType': 'incidence rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.96', 'ciLowerLimit': '0.45', 'ciUpperLimit': '2.04', 'estimateComment': 'We calculated incidence rate ratio, where the pregnancy incidence rate for the intervention arm represents the numerator and the pregnancy incidence rate for the control arm represents the denominator.', 'groupDescription': 'Power was not calculated for all the secondary outcomes.', 'statisticalMethod': 'z-test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'We used z-test to compare pregnancy incidence rates between the arms. We did not use log-rank test because we did not present survival curves.'}], 'paramType': 'NUMBER', 'timeFrame': 'Between 2012 and 2015, up to 28 months', 'description': 'Time to pregnancy, was as the difference between the estimated date of conception and the enrolment date, plus one. The date of conception was defined as 14 days after the last normal menstrual period or the estimated date of delivery minus 40 weeks if the first date of last normal menstrual period is not available or the midpoint between the date of the first positive pregnancy test and the date of the previous negative pregnancy test. The censoring time for a woman who did not become pregnant during the study equals the difference between the calculated censoring date and the enrolment date, plus one.', 'unitOfMeasure': 'Incidence rate/100 women years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat population(all participants who were randomized, met pre-randomization eligibility criteria and who have post-enrollment follow-up data).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Adherence >80%.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': '1% tenofovir gel provision through a public sector family planning services with 2-3 monthly provision and monitoring and the use of Quality Improvement methodology to promote reliable service delivery\n\n1% tenofovir gel: Participants will be randomized to receive 1% tenofovir gel through either:\n\n* Public sector family planning services with 2-3 monthly provision and monitoring of 1% tenofovir gel and the use of Quality Improvement methodology to promote reliable service delivery (intervention arm), or\n* The CAPRISA research clinics with monthly provision and monitoring of 1% tenofovir gel (control arm).'}, {'id': 'OG001', 'title': 'Control', 'description': 'monthly 1% tenofovir gel provision and monitoring through CAPRISA research clinics\n\n1% tenofovir gel: Participants will be randomized to receive 1% tenofovir gel through either:\n\n* Public sector family planning services with 2-3 monthly provision and monitoring of 1% tenofovir gel and the use of QI methodology to promote reliable service delivery (intervention arm), or\n* The CAPRISA research clinics with monthly provision and monitoring of 1% tenofovir gel (control arm).'}], 'classes': [{'categories': [{'measurements': [{'value': '70.2', 'groupId': 'OG000', 'lowerLimit': '63.1', 'upperLimit': '76.7'}, {'value': '65.2', 'groupId': 'OG001', 'lowerLimit': '57.8', 'upperLimit': '72.1'}]}]}], 'analyses': [{'pValue': '0.304', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.08', 'ciLowerLimit': '0.94', 'ciUpperLimit': '1.24', 'groupDescription': 'Power was not calculated for all secondary outcomes.', 'statisticalMethod': 'Regression, Log-binomial', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Between 2012 and 2015, up to 28 months', 'description': 'Self-reported adherence to the tenofovir gel dosing strategy.Gel adherence was defined as the estimated proportion of reported sex acts covered by two gel doses and calculated for each woman by dividing half the number of returned used applicators each month by the number of reported sex acts that month.For participants attending 2-3 monthly clinic visits, their number of gels used in the last 30 days will be estimated as the total number of returned used gels, divided by the number of days between the current and the previous visit, times 30.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'This is a subset of intent to treat population. It includes all participants who returned used gel applicators and also reported sex during follow-up.'}, {'type': 'SECONDARY', 'title': 'HIV Viral Load Among HIV Seroconverters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': '1% tenofovir gel provision through a public sector family planning services with 2-3 monthly provision and monitoring and the use of Quality Improvement methodology to promote reliable service delivery\n\n1% tenofovir gel: Participants will be randomized to receive 1% tenofovir gel through either:\n\n* Public sector family planning services with 2-3 monthly provision and monitoring of 1% tenofovir gel and the use of Quality Improvement methodology to promote reliable service delivery (intervention arm), or\n* The CAPRISA research clinics with monthly provision and monitoring of 1% tenofovir gel (control arm).'}, {'id': 'OG001', 'title': 'Control', 'description': 'monthly 1% tenofovir gel provision and monitoring through CAPRISA research clinics\n\n1% tenofovir gel: Participants will be randomized to receive 1% tenofovir gel through either:\n\n* Public sector family planning services with 2-3 monthly provision and monitoring of 1% tenofovir gel and the use of QI methodology to promote reliable service delivery (intervention arm), or\n* The CAPRISA research clinics with monthly provision and monitoring of 1% tenofovir gel (control arm).'}], 'classes': [{'categories': [{'measurements': [{'value': '4.4', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '4.8', 'spread': '0.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.455', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Between 2012 and 2015, up to 28 months', 'description': 'This is mean log transformed HIV viral load measured at the first visit post HIV infection.', 'unitOfMeasure': 'log10 copies/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who became HIV infected'}, {'type': 'SECONDARY', 'title': 'Tenofovir Resistance Among HIV Seroconverters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': '1% tenofovir gel provision through a public sector family planning services with 2-3 monthly provision and monitoring and the use of Quality Improvement methodology to promote reliable service delivery\n\n1% tenofovir gel: Participants will be randomized to receive 1% tenofovir gel through either:\n\n* Public sector family planning services with 2-3 monthly provision and monitoring of 1% tenofovir gel and the use of Quality Improvement methodology to promote reliable service delivery (intervention arm), or\n* The CAPRISA research clinics with monthly provision and monitoring of 1% tenofovir gel (control arm).'}, {'id': 'OG001', 'title': 'Control', 'description': 'monthly 1% tenofovir gel provision and monitoring through CAPRISA research clinics\n\n1% tenofovir gel: Participants will be randomized to receive 1% tenofovir gel through either:\n\n* Public sector family planning services with 2-3 monthly provision and monitoring of 1% tenofovir gel and the use of QI methodology to promote reliable service delivery (intervention arm), or\n* The CAPRISA research clinics with monthly provision and monitoring of 1% tenofovir gel (control arm).'}], 'timeFrame': 'Between 2012 and 2015, up to 28 months', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to lack of funding, tenofovir resistance testing was not done in this study. However, we do have stored samples to fall back onto, should we secure funding.'}, {'type': 'SECONDARY', 'title': 'Human Papillomavirus Incidence Rates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': '1% tenofovir gel provision through a public sector family planning services with 2-3 monthly provision and monitoring and the use of QI methodology to promote reliable service delivery\n\n1% tenofovir gel: Participants will be randomized to receive 1% tenofovir gel through either:\n\n* Public sector family planning services with 2-3 monthly provision and monitoring of 1% tenofovir gel and the use of QI methodology to promote reliable service delivery (intervention arm), or\n* The CAPRISA research clinics with monthly provision and monitoring of 1% tenofovir gel (control arm).'}, {'id': 'OG001', 'title': 'Control', 'description': 'monthly 1% tenofovir gel provision and monitoring through CAPRISA research clinics\n\n1% tenofovir gel: Participants will be randomized to receive 1% tenofovir gel through either:\n\n* Public sector family planning services with 2-3 monthly provision and monitoring of 1% tenofovir gel and the use of QI methodology to promote reliable service delivery (intervention arm), or\n* The CAPRISA research clinics with monthly provision and monitoring of 1% tenofovir gel (control arm).'}], 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '2.9'}, {'value': '3.0', 'groupId': 'OG001', 'lowerLimit': '1.4', 'upperLimit': '5.8'}]}]}], 'analyses': [{'pValue': '0.097', 'groupIds': ['OG000', 'OG001'], 'paramType': 'incidence rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.33', 'ciLowerLimit': '0.06', 'ciUpperLimit': '1.32', 'estimateComment': 'We calculated incidence rate ratio, where the HPV incidence rate for the intervention arm represents the numerator and the HPV incidence rate for the control arm represents the denominator.', 'statisticalMethod': 'z-test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Between 2012 and 2015, up to 28 months', 'description': 'For the calculation of the incidence rate, seroconversion was assumed to have occurred at the midpoint between the first positive HPV test and the previous HPV negative test.', 'unitOfMeasure': 'Incidence rate/100 women years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'This is the subset of intent to treat population. It includes all participants who had HPV negative results at randomisation.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Detectable Tenofovir Levels From Vaginal Samples at 12 Months of Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '156', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': '1% tenofovir gel provision through a public sector family planning services with 2-3 monthly provision and monitoring and the use of QI methodology to promote reliable service delivery\n\n1% tenofovir gel: Participants will be randomized to receive 1% tenofovir gel through either:\n\n* Public sector family planning services with 2-3 monthly provision and monitoring of 1% tenofovir gel and the use of QI methodology to promote reliable service delivery (intervention arm), or\n* The CAPRISA research clinics with monthly provision and monitoring of 1% tenofovir gel (control arm).'}, {'id': 'OG001', 'title': 'Control', 'description': 'monthly 1% tenofovir gel provision and monitoring through CAPRISA research clinics\n\n1% tenofovir gel: Participants will be randomized to receive 1% tenofovir gel through either:\n\n* Public sector family planning services with 2-3 monthly provision and monitoring of 1% tenofovir gel and the use of QI methodology to promote reliable service delivery (intervention arm), or\n* The CAPRISA research clinics with monthly provision and monitoring of 1% tenofovir gel (control arm).'}], 'classes': [{'categories': [{'measurements': [{'value': '39.5', 'groupId': 'OG000', 'lowerLimit': '32.2', 'upperLimit': '47.3'}, {'value': '43.6', 'groupId': 'OG001', 'lowerLimit': '36.1', 'upperLimit': '51.4'}]}]}], 'analyses': [{'pValue': '0.462', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.91', 'ciLowerLimit': '0.70', 'ciUpperLimit': '1.18', 'statisticalMethod': 'Regression, Log-binomial', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'All participants with drug levels at 12 months of follow-up', 'description': 'Percentage of participants with detectable tenofovir levels from vaginal samples at 12 months of follow-up. All drug levels below limit of quantification were considered to be undetectable.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with drug levels measured at 12 months of follow-up'}, {'type': 'SECONDARY', 'title': 'Product Acceptability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': '1% tenofovir gel provision through a public sector family planning services with 2-3 monthly provision and monitoring and the use of Quality Improvement methodology to promote reliable service delivery\n\n1% tenofovir gel: Participants will be randomized to receive 1% tenofovir gel through either:\n\n* Public sector family planning services with 2-3 monthly provision and monitoring of 1% tenofovir gel and the use of Quality Improvement methodology to promote reliable service delivery (intervention arm), or\n* The CAPRISA research clinics with monthly provision and monitoring of 1% tenofovir gel (control arm).'}, {'id': 'OG001', 'title': 'Control', 'description': 'monthly 1% tenofovir gel provision and monitoring through CAPRISA research clinics\n\n1% tenofovir gel: Participants will be randomized to receive 1% tenofovir gel through either:\n\n* Public sector family planning services with 2-3 monthly provision and monitoring of 1% tenofovir gel and the use of QI methodology to promote reliable service delivery (intervention arm), or\n* The CAPRISA research clinics with monthly provision and monitoring of 1% tenofovir gel (control arm).'}], 'classes': [{'categories': [{'measurements': [{'value': '180', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At study completion, up to 28 months', 'description': 'This is the number of participants who reported that they liked the study product. The questionnaire was administered at study exit, therefore participants who were loss to follow-up and those who died could not complete the questionnaire.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed product acceptability questionnaire at study exit'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention', 'description': '1% tenofovir gel provision through a public sector family planning services with 2-3 monthly provision and monitoring and the use of Quality Improvement methodology to promote reliable service delivery\n\n1% tenofovir gel: Participants will be randomized to receive 1% tenofovir gel through either:\n\n* Public sector family planning services with 2-3 monthly provision and monitoring of 1% tenofovir gel and the use of QI methodology to promote reliable service delivery (intervention arm), or\n* The CAPRISA research clinics with monthly provision and monitoring of 1% tenofovir gel (control arm).'}, {'id': 'FG001', 'title': 'Control', 'description': 'monthly 1% tenofovir gel provision and monitoring through CAPRISA research clinics\n\n1% tenofovir gel: Participants will be randomized to receive 1% tenofovir gel through either:\n\n* Public sector family planning services with 2-3 monthly provision and monitoring of 1% tenofovir gel and the use of QI methodology to promote reliable service delivery (intervention arm), or\n* The CAPRISA research clinics with monthly provision and monitoring of 1% tenofovir gel (control arm).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '189'}, {'groupId': 'FG001', 'numSubjects': '183'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '174'}, {'groupId': 'FG001', 'numSubjects': '167'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '16'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Relocated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Investigator decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': '448 were assessed for eligibility and 382 were randomized. However, only 372 were eligible for study participation. Of the 10 who were ineligibly enrolled: 6 were HIV positive at enrollment, 2 were co-enrolled in another trial, 1 had no post-randomization follow-up data and 1 was pregnant at enrollment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'BG000'}, {'value': '183', 'groupId': 'BG001'}, {'value': '372', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention', 'description': '1% tenofovir gel provision through a public sector family planning services with 2-3 monthly provision and monitoring and the use of QI methodology to promote reliable service delivery\n\n1% tenofovir gel: Participants will be randomized to receive 1% tenofovir gel through either:\n\n* Public sector family planning services with 2-3 monthly provision and monitoring of 1% tenofovir gel and the use of QI methodology to promote reliable service delivery (intervention arm), or\n* The CAPRISA research clinics with monthly provision and monitoring of 1% tenofovir gel (control arm).'}, {'id': 'BG001', 'title': 'Control', 'description': 'monthly 1% tenofovir gel provision and monitoring through CAPRISA research clinics\n\n1% tenofovir gel: Participants will be randomized to receive 1% tenofovir gel through either:\n\n* Public sector family planning services with 2-3 monthly provision and monitoring of 1% tenofovir gel and the use of QI methodology to promote reliable service delivery (intervention arm), or\n* The CAPRISA research clinics with monthly provision and monitoring of 1% tenofovir gel (control arm).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'BG000'}, {'value': '183', 'groupId': 'BG001'}, {'value': '372', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '29.5', 'spread': '5.8', 'groupId': 'BG000'}, {'value': '29.3', 'spread': '5.3', 'groupId': 'BG001'}, {'value': '29.4', 'spread': '5.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'BG000'}, {'value': '183', 'groupId': 'BG001'}, {'value': '372', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '189', 'groupId': 'BG000'}, {'value': '183', 'groupId': 'BG001'}, {'value': '372', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'BG000'}, {'value': '183', 'groupId': 'BG001'}, {'value': '372', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '189', 'groupId': 'BG000'}, {'value': '183', 'groupId': 'BG001'}, {'value': '372', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'South Africa', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'BG000'}, {'value': '183', 'groupId': 'BG001'}, {'value': '372', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '189', 'groupId': 'BG000'}, {'value': '183', 'groupId': 'BG001'}, {'value': '372', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex acts in past 30 days', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'BG000'}, {'value': '183', 'groupId': 'BG001'}, {'value': '372', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000', 'lowerLimit': '3', 'upperLimit': '8'}, {'value': '4', 'groupId': 'BG001', 'lowerLimit': '2', 'upperLimit': '8'}, {'value': '4', 'groupId': 'BG002', 'lowerLimit': '2', 'upperLimit': '8'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Acts', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Contraception', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'BG000'}, {'value': '183', 'groupId': 'BG001'}, {'value': '372', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Injectable', 'measurements': [{'value': '139', 'groupId': 'BG000'}, {'value': '140', 'groupId': 'BG001'}, {'value': '279', 'groupId': 'BG002'}]}, {'title': 'Oral', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}, {'title': 'Sterilized', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'HSV-2 prevalence', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '182', 'groupId': 'BG000'}, {'value': '179', 'groupId': 'BG001'}, {'value': '361', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '174', 'groupId': 'BG000'}, {'value': '159', 'groupId': 'BG001'}, {'value': '333', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'A total of 9 participants had equivocal results and 2 had missing results.'}, {'title': 'HPV prevalence', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'BG000'}, {'value': '179', 'groupId': 'BG001'}, {'value': '365', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Total of 5 participants had equivocal and 2 had missing results.'}], 'populationDescription': 'Intent to treat population was analyzed. All participants who were randomized and met the pre-enrollment eligibility criteria.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 372}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-07', 'studyFirstSubmitDate': '2012-07-05', 'resultsFirstSubmitDate': '2019-10-10', 'studyFirstSubmitQcDate': '2012-09-21', 'lastUpdatePostDateStruct': {'date': '2019-11-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-11-07', 'studyFirstPostDateStruct': {'date': '2012-09-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-11-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Number of Returned Used Applicators Per Month (i.e in 30 Days)', 'timeFrame': 'Between 2012 to 2015, up to 28 months', 'description': 'The primary endpoint is the mean number of returned used applicators per month. Since participants in the intervention arm followed two and three monthly schedule (as opposed to monthly in the intervention arm), the number of returned used applicators per month for each participant will be estimated as the total number of returned applicators at that visit divided by the number of days since the previous visit, multiplied by 30. Thus a uniform distribution of gel use will be assumed in participants whom we did not see monthly. Intent to treat and per protocol analyses were carried out of this outcome. Intent to treat population includes all participants who were randomized, met pre-randomization eligibility criteria and who have post-enrollment follow-up data. The per protocol population is a subset of the intent to treat population.The per-protocol analysis excluded visits where no gel had been dispensed for \\>120 days.'}], 'secondaryOutcomes': [{'measure': 'HIV Incidence Rates', 'timeFrame': 'Between 2012 and 2015, up to 28 months', 'description': 'Time to HIV infection was calculated as the difference between estimated date of infection (midpoint between the last negative HIV test date and the first confirmed positive HIV test date) and enrolment date, plus one. Where a participant has a positive PCR and a negative rapid test on the same date, the date of infection is calculated as 14 days prior to this date. Women who do not become HIV positive before their last study visit will be censored on the day of their last negative HIV test. Their follow-up time will be calculated as the difference between date of censoring and enrolment date, plus one.'}, {'measure': 'Pregnancy Incidence Rates', 'timeFrame': 'Between 2012 and 2015, up to 28 months', 'description': 'Time to pregnancy, was as the difference between the estimated date of conception and the enrolment date, plus one. The date of conception was defined as 14 days after the last normal menstrual period or the estimated date of delivery minus 40 weeks if the first date of last normal menstrual period is not available or the midpoint between the date of the first positive pregnancy test and the date of the previous negative pregnancy test. The censoring time for a woman who did not become pregnant during the study equals the difference between the calculated censoring date and the enrolment date, plus one.'}, {'measure': 'Percentage of Participants Achieving Adherence >80%.', 'timeFrame': 'Between 2012 and 2015, up to 28 months', 'description': 'Self-reported adherence to the tenofovir gel dosing strategy.Gel adherence was defined as the estimated proportion of reported sex acts covered by two gel doses and calculated for each woman by dividing half the number of returned used applicators each month by the number of reported sex acts that month.For participants attending 2-3 monthly clinic visits, their number of gels used in the last 30 days will be estimated as the total number of returned used gels, divided by the number of days between the current and the previous visit, times 30.'}, {'measure': 'HIV Viral Load Among HIV Seroconverters', 'timeFrame': 'Between 2012 and 2015, up to 28 months', 'description': 'This is mean log transformed HIV viral load measured at the first visit post HIV infection.'}, {'measure': 'Tenofovir Resistance Among HIV Seroconverters', 'timeFrame': 'Between 2012 and 2015, up to 28 months'}, {'measure': 'Human Papillomavirus Incidence Rates', 'timeFrame': 'Between 2012 and 2015, up to 28 months', 'description': 'For the calculation of the incidence rate, seroconversion was assumed to have occurred at the midpoint between the first positive HPV test and the previous HPV negative test.'}, {'measure': 'Percentage of Participants With Detectable Tenofovir Levels From Vaginal Samples at 12 Months of Follow-up', 'timeFrame': 'All participants with drug levels at 12 months of follow-up', 'description': 'Percentage of participants with detectable tenofovir levels from vaginal samples at 12 months of follow-up. All drug levels below limit of quantification were considered to be undetectable.'}, {'measure': 'Product Acceptability', 'timeFrame': 'At study completion, up to 28 months', 'description': 'This is the number of participants who reported that they liked the study product. The questionnaire was administered at study exit, therefore participants who were loss to follow-up and those who died could not complete the questionnaire.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['microbicides', 'women', 'HIV prevention', 'PrEP', 'Tenofovir gel'], 'conditions': ['HIV']}, 'referencesModule': {'references': [{'pmid': '20643915', 'type': 'BACKGROUND', 'citation': 'Abdool Karim Q, Abdool Karim SS, Frohlich JA, Grobler AC, Baxter C, Mansoor LE, Kharsany AB, Sibeko S, Mlisana KP, Omar Z, Gengiah TN, Maarschalk S, Arulappan N, Mlotshwa M, Morris L, Taylor D; CAPRISA 004 Trial Group. Effectiveness and safety of tenofovir gel, an antiretroviral microbicide, for the prevention of HIV infection in women. Science. 2010 Sep 3;329(5996):1168-74. doi: 10.1126/science.1193748. Epub 2010 Jul 19.'}, {'pmid': '28348164', 'type': 'DERIVED', 'citation': 'Mngadi KT, Singh JA, Mansoor LE, Wassenaar DR. Undue inducement: a case study in CAPRISA 008. J Med Ethics. 2017 Dec;43(12):824-828. doi: 10.1136/medethics-2016-103414. Epub 2017 Mar 27.'}, {'pmid': '25527071', 'type': 'DERIVED', 'citation': 'Mansoor LE, Abdool Karim Q, Mngadi KT, Dlamini S, Montague C, Nkomonde N, Mvandaba N, Baxter C, Gengiah TN, Samsunder N, Dawood H, Grobler A, Frohlich JA, Abdool Karim SS. Assessing the implementation effectiveness and safety of 1% tenofovir gel provision through family planning services in KwaZulu-Natal, South Africa: study protocol for an open-label randomized controlled trial. Trials. 2014 Dec 19;15:496. doi: 10.1186/1745-6215-15-496.'}], 'seeAlsoLinks': [{'url': 'http://www.caprisa.org', 'label': 'Centre for the AIDS Programme of Research in South Africa web site'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the effectiveness of an implementation model which integrates tenofovir gel provision into existing family planning services.', 'detailedDescription': 'The CAPRISA 008 trial is a two-arm, open-label, randomized controlled trial that is being conducted at the CAPRISA eThekwini and CAPRISA Vulindlela Clinics and their neighboring public sector family planning services in KwaZulu-Natal, South Africa. Up to 700 consenting sexually active, HIV-uninfected women aged 18 years and older who previously participated in an antiretroviral (ARV) prevention study will be enrolled and followed for a maximum 30 months. All women will be provided with 1% tenofovir gel but will be randomised to either receive their gel through a public sector family planning services with 2-3 monthly provision (intervention arm) or through the CAPRISA research clinics with monthly provision (control arm).\n\nAll women in the trial will be provided with the standard package of HIV prevention and reproductive health services. Participants in both study arms will be provided with a supply of single-use, pre-filled applicators of 1% tenofovir gel. While in the study, participants will be advised and supported to follow the CAPRISA 004 pre- and post-dosing strategy, namely BAT24, where the first dose of tenofovir gel is applied within 12 hours before anticipated coitus and a second dose as soon as possible but within 12 hours after coitus, with a maximum of two doses of gel in a 24-hour period.\n\nThe primary objective of this trial is to assess the effectiveness of an implementation model for tenofovir gel provision through family planning services.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years and older\n* Women who previously participated in an ARV prevention study\n* Currently utilizing or agreeing to attend designated public sector family planning services\n* Able and willing to provide first person informed consent to be screened for, and to enroll in, the study\n* Able and willing to provide adequate locator information for study retention purposes\n* Sexually active (at least one coital act in the last 3 months prior to screening)\n* HIV negative (by HIV testing performed by study staff within 30 days of enrollment)\n* Negative pregnancy test performed by study staff within 21 days of enrollment\n* Agree to use a non-barrier form of contraceptive\n* Agree to adhere to study visits and procedures\n\nExclusion Criteria:\n\n* Has a creatinine clearance \\< 50ml/min\n* Has any other condition that, based on the opinion of the Investigator or designee, would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives'}, 'identificationModule': {'nctId': 'NCT01691768', 'briefTitle': 'Implementation Effectiveness and Safety of Tenofovir Gel Provision Through Family Planning Services', 'nctIdAliases': ['NCT01645813'], 'organization': {'class': 'NETWORK', 'fullName': 'Centre for the AIDS Programme of Research in South Africa'}, 'officialTitle': 'Open-Label Randomized Controlled Trial to Assess the Implementation Effectiveness and Safety of 1% Tenofovir Gel Provision Through Family Planning Services in KwaZulu-Natal, South Africa', 'orgStudyIdInfo': {'id': 'CAPRISA008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': '1% tenofovir gel provision through a public sector family planning services with 2-3 monthly provision and monitoring and the use of Quality Improvement methodology to promote reliable service delivery', 'interventionNames': ['Drug: 1% tenofovir gel']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'monthly 1% tenofovir gel provision and monitoring through CAPRISA research clinics', 'interventionNames': ['Drug: 1% tenofovir gel']}], 'interventions': [{'name': '1% tenofovir gel', 'type': 'DRUG', 'description': 'Participants will be randomized to receive 1% tenofovir gel through either:\n\n* Public sector family planning services with 2-3 monthly provision and monitoring of 1% tenofovir gel and the use of QI methodology to promote reliable service delivery (intervention arm), or\n* The CAPRISA research clinics with monthly provision and monitoring of 1% tenofovir gel (control arm).', 'armGroupLabels': ['Control', 'Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4001', 'city': 'Durban', 'state': 'KwaZulu-Natal', 'country': 'South Africa', 'facility': 'CAPRISA eThekwini Clinical Research Site', 'geoPoint': {'lat': -29.8579, 'lon': 31.0292}}, {'city': 'Pietermaritzburg', 'state': 'KwaZulu-Natal', 'country': 'South Africa', 'facility': 'CAPRISA Vulindlela Clinical Research Site', 'geoPoint': {'lat': -29.61679, 'lon': 30.39278}}], 'overallOfficials': [{'name': 'Quarraisha Abdool Karim, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre for the AIDS Programme of Research in South Africa'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre for the AIDS Programme of Research in South Africa', 'class': 'NETWORK'}, 'collaborators': [{'name': 'CONRAD', 'class': 'OTHER'}, {'name': 'Gilead Sciences', 'class': 'INDUSTRY'}, {'name': 'FHI 360', 'class': 'OTHER'}, {'name': 'Institute for Healthcare Improvement', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Scientific Director', 'investigatorFullName': 'Dr Quarraisha Abdool Karim', 'investigatorAffiliation': 'Centre for the AIDS Programme of Research in South Africa'}}}}