Pharmacy and Poisons Board

Pharmacy and Poisons Board

Ensuring Safety, Quality and Efficacy of Medicines

Protocol No: ECCT/17/05/02 Date of Protocol: 20-09-2016

Abstract of Study:

Purpose: The goals of this project are; to identify and test 700 men who have sex with men (MSM); to assess the success of a comprehensive package of find, test, link and retain in care (FTLR) interventions delivered to HIV-infected MSM; to retain those who test negative in a peer-led behavioral risk reduction program that includes retesting every 3 months; and to offer pre exposure prophylaxis (PrEP) to a subset of the negative men who are at high risk for HIV acquistion.

Significance: This study will generate evidence to inform feasibility, acceptability, and expected outputs necessary to guide PEPFAR programming for expansion of counseling, testing, and comprehensive care and treatment as effective HIV prevention interventions adapted for MSM in sub-Saharan Africa.

Design: This is an observational cohort study. Over 6 months, 700 MSM will be tested and counseled for HIV. Outreach will occur using existing peer networks, snowballing, and Time Location Recruitment (TLR) strategies. Those who meet the eligibility criteria will be asked to enroll in the study. HIV-positive participants will be recruited into care and offered ART, regardless of CD4 count, then followed up for retention in care and treatment adherence. HIV-negative participants will be recruited to a risk reduction program with quarterly counseling, linkage to support groups, and repeat HIV counseling and testing every 3 months. A subset of HIV-negative participants will be offered PrEP. Each participant will be followed for 12 months from enrolment or from PrEP initiation, during which structured HIV behavioral assessments, medical examinations, and collection of biological samples for STI/HIV tests will be conducted. Mid-way and exit qualitative interviews with participants will explore barriers to retention in periodic testing and HIV prevention. Participants who do not complete 12 months of follow-up will be contacted to explore reasons for no longer participating. Approximately 30 clinicians and peer outreach staff will be interviewed to get their views on unmet needs and program improvement.

Study Population: Men who report oral or anal sex with a man in the past 6 months, are ≥18 years of age, and are residents of Kisumu, irrespective of HIV infection status.      

Study Size: A total of approximately 700 men will be enrolled, plus approximately 30 staff.

Study: Total study duration is 24 months

Study Aims:             Aim 1: To find and test 700 MSM for HIV

         Aim 2: To link and retain HIV-positive MSM in HIV care including ART

         Aim 3: To link and retain HIV-negative MSM in a non-ART care and risk reduction program including retesting every 3 months post-enrollment

         Aim 4: To assess uptake and adherence to PrEP among a subset of high risk HIV-negative MSM

Study Sites:             Anza Mapema, Tom Mboya, Kisumu and Kisumu Town Office

Study Title:

Expanding test and treat for HIV prevention in MSM in Kisumu, Kenya: The Anza Mapema Study