Ignite Creation Date:
2024-05-06 @ 2:49 AM
Last Modification Date:
2024-10-26 @ 11:24 AM
Study NCT ID:
NCT02135003
Status:
COMPLETED
Last Update Posted:
2014-05-09
First Post:
2014-04-29
Brief Title:
Non-enrolment and Non-adherence to HIV Care in a Community-based Program Rakai Uganda
Sponsor:
Rakai Health Sciences Program
Organization:
Rakai Health Sciences Program
Study Overview
Official Title:
Non-enrolment and Non-adherence to HIV Care in a Community-based Program Rakai Uganda
Status:
COMPLETED
Status Verified Date:
2014-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Hypothesis 1 The proportion of pre-ART patients whose CD4 cell counts decline to ART-eligibility within 48 weeks will be lower in intervention compared to the non-intervention arm
Hypothesis 2 PLHIV who receive the PSCB intervention will experience lower rates of morbidity or death over the follow-up period compared to patients not receiving the intervention
Hypothesis 3 PLHIV who receive the PCSB intervention will have better adherence to scheduled clinic appointments compared to those not receiving the intervention
Hypothesis 2 PLHIV who receive the PSCB intervention will experience lower rates of morbidity or death over the follow-up period compared to patients not receiving the intervention
Hypothesis 3 PLHIV who receive the PCSB intervention will have better adherence to scheduled clinic appointments compared to those not receiving the intervention
Detailed Description:
A randomized trial to assess the effect of patient-selected care buddies PSCB on adherence to pre-ART clinic appointments clinical and immunologic outcomes of patients receiving pre-Anti-retroviral therapy pre-ART HIV care in a rural community HIV care program
Standard of care Patients enrolled for pre-ART care CD4 250 cellsul received general health education scheduled and unscheduled clinical monitoring CD4 testing and other clinically indicated investigations treatment of opportunistic infections and cotrimoxazole prophylaxis A client was expected to come to the clinic at least once in three months
Patient selected Care buddy intervention In addition to standard of care above pre-ART patients randomized to PSCB arm were requested to choose a care buddy who was aware of the patients HIV infection and resides in the same household or in close proximity Care buddies attended at least two HIV health education sessions similar to those provided to study participants Information on HIV and the importance of adhering to scheduled clinic visits and to prescribed medications were emphasized Buddies were requested to remind participants to take their prophylactic treatments and remind them of clinic appointments No compensation for participation was given to buddies
Randomization procedure Randomization and concealment This was done to minimize systematic bias in the allocation of patients to the intervention or non-intervention study arms I used stratified block randomization to restrict chance imbalances so as to ensure that the study arms were as alike as possible for patient enrollment factors including key factors such as sex and CD4 which can have an effect on the outcomes such as adherence to pre-ART scheduled clinic appointments A set of permuted blocks were generated for each combination of stratification factors In this study these factors included patient sex and CD4 cell count
Concealment of the patient allocation to study arms was done to avoid both conscious and unconscious selection of patients into the study The research assistants assessed the eligibility of the patients sought their consent for study participation and then the enrollment officer with the sealed trial randomization envelopes let the patient pick the envelope containing the study arm To further ensure unbiased allocation of patients to study arms I used varying block size specifically size 6 so that the recruiting officer does not guess which study arm follows Concealment through sequence generation I used a computer-generated allocation sequence with a randomization ratio of 11 to PSCB or SOC We collected data using interviewer-administered questionnaires and HIV clinic forms Patients received a questionnaire at baseline six months and 12 months follow up visits All visits were conducted at the HIV clinics At baseline visit we collected socio-demographic information including level of education occupation marital status distance to the HIV clinic willingness to select a buddy as well as readiness to disclose HIV status to a buddy At both the 6 and 12 month follow up visits information on continued possession of a buddy change or loss of a buddy relationship and perceived helpfulness of their buddy if in intervention arm self-reported adherence to clinic appointments and cotrimoxazole quality of life and sexual behaviors including sexual activity condom use and number of sexual partners marital and non-marital were collected As per clinic schedules patients were required to come to the clinic for cotrimoxazole refills at least 3 monthly and to have a blood draw for CD4 testing as follows at 3 months if previous CD4 count was 251-350 cellsul or after six months if CD4 was greater than 350 cellsul Routine clinic data collected on clinic forms included patient visit data visit date number of cotrimoxazole pills dispensed blood samples taken for testing health status eg opportunistic infections diagnosed Karnofsky score WHO staging and laboratory results including CD4 counts and any other investigations as clinically indicated Blood for CD4 testing was collected from participants at the various community clinics and transported to the central Rakai Health Sciences Program laboratory in KalisizoCD4 counts were assessed by flow cytometry using a FACS Calibur Becton Dickinson San Jose CA USA
Standard of care Patients enrolled for pre-ART care CD4 250 cellsul received general health education scheduled and unscheduled clinical monitoring CD4 testing and other clinically indicated investigations treatment of opportunistic infections and cotrimoxazole prophylaxis A client was expected to come to the clinic at least once in three months
Patient selected Care buddy intervention In addition to standard of care above pre-ART patients randomized to PSCB arm were requested to choose a care buddy who was aware of the patients HIV infection and resides in the same household or in close proximity Care buddies attended at least two HIV health education sessions similar to those provided to study participants Information on HIV and the importance of adhering to scheduled clinic visits and to prescribed medications were emphasized Buddies were requested to remind participants to take their prophylactic treatments and remind them of clinic appointments No compensation for participation was given to buddies
Randomization procedure Randomization and concealment This was done to minimize systematic bias in the allocation of patients to the intervention or non-intervention study arms I used stratified block randomization to restrict chance imbalances so as to ensure that the study arms were as alike as possible for patient enrollment factors including key factors such as sex and CD4 which can have an effect on the outcomes such as adherence to pre-ART scheduled clinic appointments A set of permuted blocks were generated for each combination of stratification factors In this study these factors included patient sex and CD4 cell count
Concealment of the patient allocation to study arms was done to avoid both conscious and unconscious selection of patients into the study The research assistants assessed the eligibility of the patients sought their consent for study participation and then the enrollment officer with the sealed trial randomization envelopes let the patient pick the envelope containing the study arm To further ensure unbiased allocation of patients to study arms I used varying block size specifically size 6 so that the recruiting officer does not guess which study arm follows Concealment through sequence generation I used a computer-generated allocation sequence with a randomization ratio of 11 to PSCB or SOC We collected data using interviewer-administered questionnaires and HIV clinic forms Patients received a questionnaire at baseline six months and 12 months follow up visits All visits were conducted at the HIV clinics At baseline visit we collected socio-demographic information including level of education occupation marital status distance to the HIV clinic willingness to select a buddy as well as readiness to disclose HIV status to a buddy At both the 6 and 12 month follow up visits information on continued possession of a buddy change or loss of a buddy relationship and perceived helpfulness of their buddy if in intervention arm self-reported adherence to clinic appointments and cotrimoxazole quality of life and sexual behaviors including sexual activity condom use and number of sexual partners marital and non-marital were collected As per clinic schedules patients were required to come to the clinic for cotrimoxazole refills at least 3 monthly and to have a blood draw for CD4 testing as follows at 3 months if previous CD4 count was 251-350 cellsul or after six months if CD4 was greater than 350 cellsul Routine clinic data collected on clinic forms included patient visit data visit date number of cotrimoxazole pills dispensed blood samples taken for testing health status eg opportunistic infections diagnosed Karnofsky score WHO staging and laboratory results including CD4 counts and any other investigations as clinically indicated Blood for CD4 testing was collected from participants at the various community clinics and transported to the central Rakai Health Sciences Program laboratory in KalisizoCD4 counts were assessed by flow cytometry using a FACS Calibur Becton Dickinson San Jose CA USA
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None