Expanding test and treat for HIV prevention in MSM in Kisumu, Kenya

PI: Fredrick O. Otieno (NRHS)
Investigators: Robert C. Bailey (UIC), Susan Graham (UW), Supriya Mehta (UIC), Donath Emusu (CDC) and Boaz Otieno Nyunya (CDC)
Duration: September 2013 – September 2016
Status: Enrolling
Study Sites:

Anza Mapema Study Clinic, Tom Mboya Estate
Anza Mapema CBD Clinic

Sponsor:

US Centres for Disease Control and Prevention

Purpose:

The goal of this project is 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, and to retain those who test negative in a peer-led behavioral risk reduction program that includes retesting every 3 months.

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. Each participant will be followed for 12 months, 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 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

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