Comprehensive HIV Prevention Package for MSM in Port Elizabeth

Summary

The purpose of this study is to evaluate the acceptability and uptake of a combination package of biomedical, behavioral and community-level HIV prevention interventions and services for men who have sex with men (MSM) in South Africa.

Conditions

• HIV

Interventions

BEHAVIORAL

Condom choices

Men will receive the condom package that includes an assortment of styles, sizes, features and colors at their baseline visit, and will be able to get more condoms for free at any time after that visit by coming to a study clinic during clinic hours, or during a scheduled study visit.

BEHAVIORAL

Condom-compatible lubricant choices

Men will receive condom-compatible lubricant that will include different types of lubricant (e.g., silicone-based) and different packaging (individual sachets or flat, discreet packages) at their baseline study visit, and participants will be able to access enhanced condom-compatible lubricant at any time after that visit by coming to a study clinic during clinic hours, or during a scheduled study visit.

BEHAVIORAL

Couples HIV counseling and testing (CVCT)

Participants will be invited to schedule couples voluntary HIV counseling and testing (CVCT) appointments with a clinic counselor at any point after they complete their baseline study visit.

DRUG

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)

FTC/TDF is a once daily oral tablet taken with or without food. The tablet includes 200 mg of emtricitabine (FTC) and 300 mg of tenofovir disoproxil fumarate (TDF). For men who meet eligibility criteria, Pre-exposure prophylaxis (PrEP) with Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) will be made available beginning one month into the study. Men who express interest and meet eligibility criteria at their baseline visit can initiate PrEP at 1 month if they test negative for HIV. For men with extenuating circumstances, whose risk profile changes, of those who become more comfortable with the PrEP intervention through enrollment in the study, PrEP will be available to initiate at the 4 month visit.

OTHER

HIV Testing

Rapid HIV testing at multiple time points

OTHER

Linkage to care

Men will be linked to needed services including HIV care and treatment for positives identified at baseline or during the study, including antiretroviral medications, and mental health services. At the end of their baseline visit, participants will receive service referral handouts for HIV care and treatment, mental health services, and other resources, as appropriate. Men who test positive for sexually transmitted infections (STIs )will be treated at the clinic site.

PROCEDURE

Post-exposure prophylaxis (PEP)

Two to three antiretroviral medicines as soon as possible (recommended is emtricitabine/tenofovir disoproxil fumarate plus either raltegravir or dolutegravir), but no more than 72 hours (3 days) after one may have been exposed to HIV, to try to reduce the chance of becoming HIV-positive. They must be taken for 28 days.

BEHAVIORAL

Risk-reduction counseling

Risk-reduction counseling will be provided to all men at baseline and additionally at 3, 6, and 12 month visits, with an additional counseling session for men on PrEP at their initiation visit (either month 1 or 4), their 1-month follow-up visit (either month 2 or 5) and at their 9 month visit. Risk reduction counseling will be client-centered counseling, according to CDC's Fundamentals of HIV Prevention Counseling protocol.

Sponsors & Collaborators

• Emory University

  lead OTHER

Principal Investigators

• Patrick S Sulivan, DVM, PhD · Rollins School of Public Health

• A.D. McNaghten, PhD, MHSA · Rollins School of Public Health

• Stefan Baral, MD, MPH, CCFP · Johns Hopkins Bloomberg School of Public Health

• Nancy Phaswanamafuya, PhD · Human Sciences Research Council

Study Design

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2015-05-31

Primary Completion

2016-10-31

Completion

2017-03-31

Countries

• South Africa

Study Locations