Clinical Trial: Non-enrolment and Non-adherence to HIV Care in a Community-based Program, Rakai, Uganda
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Non-enrolment and Non-adherence to HIV Care in a Community-based Program, Rakai, Uganda
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
Detailed Summary:
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 cells/ul) 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 patient's 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 p
Sponsor: Rakai Health Sciences Program
Current Primary Outcome: HIV disease progression to eligibility for anti-retroviral therapy [ Time Frame: 12 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- adherence to clinic appointments [ Time Frame: 12 months ]patient adherence to CD4 blood draw appointments
- patient quality of life [ Time Frame: 12 months ]
Original Secondary Outcome: Same as current
Information By: Rakai Health Sciences Program
Dates:
Date Received: April 29, 2014
Date Started: October 2010
Date Completion:
Last Updated: May 8, 2014
Last Verified: May 2014
