TASO, CDC Uganda in collaboration with The University of Washington Phase III, multi-site, randomized, double blind, placebo-controlled clinical trial titled: “Parallel Comparison of Tenofovir and Emtricitabine/tenofovir Pre-Exposure Prophylaxis to Prevent HIV-1 Acquisition within HIV-1 Discordant Couples” is currently in its third year of implementation.
This study has two primary objectives namely;
· To determine if PrEP prevents HIV-1 acquisition among HIV-1 uninfected persons within HIV-1 discordant couples.
· To assess the safety (side effects) of PrEP when used by HIV-1 uninfected persons within an HIV-1 discordant relationship.
The study duration: Accrual and follow-up will continue for a total of approximately 48 months, with approximately 12 additional months of follow up to complete follow up procedures for infants and sero-converters.
The TASO PrEP Projects of Tororo and Mbale started to implement the study by screening in November 2008 and enrolling discordant couples in December 2008. During the 2010 calendar year, project implementation at the two sites continued with both sites registering significant achievements.
Regulatory approvals for continuation of the PrEP study were sought and obtained from the following institutions (bodies): The Food and Drug Administration of USA- (FDA), The University of Washington Seattle Institutional Review Board (IRB), The Centers for Disease Control and Prevention –Atlanta (CDC- IRB), Uganda Virus Research Institute- Science and Ethics Committee (UVRI-SEC), Uganda National Council for Science and Technology (UNCST), National Drug Authority (NDA).
The PrEP project is in its third year of implementation but second of actual recruitment of participants also called Clinical phase. The first year of implementation was by and large a preparatory phase whereby sites where involved in regulatory and ethical clearance of the study protocol, translation of data collection tools, staff trainings, and infrastructural development. During this second year of the clinical period several targets have been achieved.
Personnel: The Current staffing levels for PrEP Mbale and Tororo sites is 31 and 29 staff respectively who are employed by TASO. Drs Jonathan Wangisi and James Campbell are the Site Principal investigators. TASO PrEP sites are endowed with highly committed and self driven staff who have worked tirelessly to ensure that despite being the last 2 sites to be activated we are among the top three sites with high rates of participant recruitment into the study.
Study Progress: By the end of recruitment and enrolment of study participants in December 2010, TASO PrEP sites had contributed 26% of the total enrolments for the entire Partners PrEP study.Tororo and Mbale had enrolled 638 and 601 HIV discordant couples respectively.
Recruitment: This was a process of identifying HIV-1 discordant heterosexual couples in which both partners met the study eligibility criteria. TASO sites established and formulated local recruitment and screening methods that operationalized protocol-specified requirements for eligibility determination.The sites’ recruitment strategies largely involved partnering with VCT/HCT service centers and HIV Care and Treatment programs in our catchment areas for referral of discordant couples. The linkage with the TASO HBHCT program contributed to the scaling up of partner testing amongst spouses of TASO registered clients. The table below summarizes key indicators of the study; by the time recruitment and enrolment were closed in November and December 2010 respectively.
Recruitment Summary for the two sites by Close of Screening and Enrolment Nov/Dec.2010
|Total number of couples Screened||1052||1012|
|Total number of couples Enrolled||601||638|
|Discordant But Not Enrolled couples (Enrolment failures)||451||374|
|Adherence to study drug based on pill count||99%||98%|
Adherence: Adherence to study drugs is very important for determining safety and effectiveness of Pre-Exposure Prophylaxis (PrEP). At each monthly visit, PrEP study staff assess participant adherence with the assigned treatment regimen through pill counts and structured interviews. Study drug adherence is targeted at 90% for this reporting time.
Retention: Once a participant is enrolled into the study, the sites make all reasonable efforts to retain him/her for the duration of the follow up period. Our scope of work establishes 95% retention of enrolled couples at 12 months of follow up.To achieve the above performance indicators, staff had been involved in extensive community pre-screening, home based HIV counseling and testing and these at times were conducted over the weekends. With these levels of commitment and sacrifice, management of PrEP acknowledges the fact that staffs’ morale needs to be maintained at the highest levels possible.During the year 2010, several milestones were achieved but notably each of the TASO/CDC sites joined the club of PrEP sites that enrolled more than 600 couples into the entire PrEP study.
Conclusion Despite the initial challenges faced by the PrEP sites, the current status of project implementation and achievements clearly signify that PrEP project is on the right course and headed to achieve its overall study targets. Credit goes to all whom in one way or the other have supported the sites to achieve the above. All the PrEP staff deserve special thanks for the efforts they put in to achieve so much within the short period of the clinical phase. The TASO PrEP/CDC sites contributed significantly towards the overall sample size for the study.We acknowledge the following: Study participants who have volunteered to be in the study, The Community Advisory Board (CAB), The University of Washington, The Bill and Melinda Gates Foundation, CDC Atlanta and Uganda, CDC Foundation, TASO Management, PrEP Study Staff of Mbale and Tororo and the other key stakeholders in the communities that we are operating in.
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