Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2026-02-25 @ 6:52 PM
Study NCT ID:
NCT01144234
Status:
COMPLETED
Last Update Posted:
2013-01-15
First Post:
2010-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Male Involvement in Antenatal Care and the Prevention Programme of Mother-to-child Transmission of HIV in Uganda
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1060}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-12', 'studyFirstSubmitDate': '2010-06-14', 'studyFirstSubmitQcDate': '2010-06-14', 'lastUpdatePostDateStruct': {'date': '2013-01-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'proportion of pregnant women who come with their partners', 'timeFrame': 'follow-up visit 4 weeks later', 'description': 'The proportion of pregnant women who come with their partners for antenatal care at the subsequent antenatal visit.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Prevention of mother-to-child transmission of HIV-1'], 'conditions': ['HIV Infection']}, 'referencesModule': {'references': [{'pmid': '21914207', 'type': 'RESULT', 'citation': 'Byamugisha R, Astrom AN, Ndeezi G, Karamagi CA, Tylleskar T, Tumwine JK. Male partner antenatal attendance and HIV testing in eastern Uganda: a randomized facility-based intervention trial. J Int AIDS Soc. 2011 Sep 13;14:43. doi: 10.1186/1758-2652-14-43.'}, {'pmid': '20573250', 'type': 'RESULT', 'citation': 'Byamugisha R, Tumwine JK, Semiyaga N, Tylleskar T. Determinants of male involvement in the prevention of mother-to-child transmission of HIV programme in Eastern Uganda: a cross-sectional survey. Reprod Health. 2010 Jun 23;7:12. doi: 10.1186/1742-4755-7-12.'}]}, 'descriptionModule': {'briefSummary': 'HIV /AIDS is a major public health problem in Uganda. The prevention of mother to child transmission of HIV/ AIDS (PMTCT) was launched in Uganda in November 2001 and in Mbale Hospital in May 2002. Currently, PMTCT services have been integrated into mainstream antenatal care services throughout the country.\n\nThough engaging men as partners is a critical component in the PMTCT programme, their involvement has been low. Measures to increase male partner involvement in the PMTCT programmes have not been explored in Uganda.\n\nObjectives: To determine the effect of a written invitation letter to the spouses of women, attending their first antenatal visit on: (a) couple attendance at subsequent antenatal clinic visits; and (b) couple acceptance of HIV testing.\n\nStudy site: The study will be carried out at Mbale Regional Referral Hospital in eastern Uganda\n\nStudy design: A randomised clinical trial among 1060 (530 intervention and 530 control) new antenatal attendees. The intervention will be a written invitation letter to their spouses.\n\nOutcome measures: The main outcome measure is the proportion of pregnant women who come with their partners for ANC at the subsequent antenatal visit.\n\nUtility: The results of this study will be utilised in re-orienting the ANC services to encourage male participation and hopefully improve the uptake of the PMTCT services at Mbale Regional Referral Hospital.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* New antenatal mothers (attendees) at Mbale regional referral hospital\n* Acceptance to attend at least two subsequent antenatal visits at Mbale hospital\n\nExclusion Criteria:\n\n* Women attending with their spouses at the first ANC visit\n* Refusal to take the letter to her spouse\n* Women with inaccessible spouses'}, 'identificationModule': {'nctId': 'NCT01144234', 'acronym': 'InvolvMaleUg', 'briefTitle': 'Male Involvement in Antenatal Care and the Prevention Programme of Mother-to-child Transmission of HIV in Uganda', 'organization': {'class': 'OTHER', 'fullName': 'Centre For International Health'}, 'officialTitle': 'Facility-based Intervention to Increase Male Involvement in Antenatal Care and the Prevention Programme of Mother-to-child Transmission of HIV in Eastern Uganda', 'orgStudyIdInfo': {'id': 'InvolvMaleUg'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Invitation letter to male spouse', 'description': 'In this arm the pregnant women got an invitation letter for the spouse to attend at the next antenatal visit', 'interventionNames': ['Behavioral: Invitation letter for male spouse']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Information letter', 'description': 'In this arm the pregnant women got an information letter about antenatal care.', 'interventionNames': ['Behavioral: Information letter']}], 'interventions': [{'name': 'Invitation letter for male spouse', 'type': 'BEHAVIORAL', 'description': 'In this arm the pregnant women got an invitation letter for the spouse to attend at the next antenatal visit', 'armGroupLabels': ['Invitation letter to male spouse']}, {'name': 'Information letter', 'type': 'BEHAVIORAL', 'description': 'In this arm the pregnant women got an information letter', 'armGroupLabels': ['Information letter']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Mbale', 'state': 'Eastern Region', 'country': 'Uganda', 'facility': 'Mbale Regional Referral Hospital', 'geoPoint': {'lat': 1.08209, 'lon': 34.17503}}], 'overallOfficials': [{'name': 'James K Tumwine, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Makerere University'}, {'name': 'Thorkild Tylleskar, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Centre for International Health, University of Bergen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre For International Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'Makerere University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}