Comprehensive HIV Prevention Package for MSM in Port Elizabeth

NCT02449733 | Completed

• 1 other identifier: IRB00079727
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

voluntary counseling and testing (VCT); couples voluntary counseling and testing (CVCT); pre-exposure prophylaxis (PrEP); homosexuality; male; South Africa

Outcome Measures

Primary Outcomes (3)

• Retention in the cohort

  Will assess the ability of the study to retain participants for full study period. This will be measured by the proportion of enrolled participants who attend all subsequent study visits through the 12-month visit.

  12 months

• Use of PrEP

  Will assess uptake of PrEP by study participants. This will be measured as the proportion of enrolled participants eligible for PrEP at the 3 and 6-month study visits who choose to initiate PrEP at those visits.

  6 months

• Incident HIV infection

  This will be measured as the number of seroconversions during follow-up among those who are HIV-uninfected at baseline.

  12 months

Secondary Outcomes (6)

• Condom use

  3 months

• Lubricant use

  3 months

• VCT and CVCT uptake

  12 months

• Serodiscordant unprotected anal intercourse (UAI)

  3 months

• Acceptability of PEP

  12 months

Study Arms (2)

HIV+ subjects

EXPERIMENTAL

Men who test positive for HIV will receive a comprehensive package of HIV prevention services, including condom choices, condom-compatible lubricant choices, risk-reduction counseling, couples HIV counseling and testing, and linkage to care

Behavioral: Condom choices; Behavioral: Condom-compatible lubricant choices; Behavioral: Couples HIV counseling and testing (CVCT); Other: Linkage to care; Behavioral: Risk-reduction counseling

HIV- subjects

EXPERIMENTAL

Men who test negative for HIV will receive a comprehensive package of HIV prevention services, including condom choices, condom-compatible lubricant choices, enhanced HIV testing options, risk-reduction counseling, couples HIV counseling and testing, linkage to care, and screening for and offering of pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP). If men test positive for HIV during the study, they will be transitioned into the HIV+ subjects arm.

Behavioral: Condom choices; Behavioral: Condom-compatible lubricant choices; Behavioral: Couples HIV counseling and testing (CVCT); Drug: Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF); Other: HIV Testing; Other: Linkage to care; Procedure: Post-exposure prophylaxis (PEP); Behavioral: Risk-reduction counseling

Interventions

Condom choices BEHAVIORAL

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.

HIV+ subjects; HIV- subjects

Condom-compatible lubricant choices BEHAVIORAL

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.

HIV+ subjects; HIV- subjects

Couples HIV counseling and testing (CVCT) BEHAVIORAL

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.

HIV+ subjects; HIV- subjects

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) DRUG

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.

Also known as: Truvada

HIV- subjects

HIV Testing OTHER

Rapid HIV testing at multiple time points

HIV- subjects

Linkage to care OTHER

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.

HIV+ subjects; HIV- subjects

Post-exposure prophylaxis (PEP) PROCEDURE

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.

HIV- subjects

Risk-reduction counseling BEHAVIORAL

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.

HIV+ subjects; HIV- subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male sex at birth
• Anal sex with another man in the past 12 months
• years of age or older
• Resident of the study city, Port Elizabeth
• Able to complete study instruments, with or without assistance, in English, Xhosa or Afrikaans
• Willing to provide contact information
• Has a phone

You may not qualify if:

• Not male sex at birth
• No self-reported anal sex with a man in the past 12 months
• Less than 18 years of age
• Not a resident of the study city
• Plans to move from the study city within the year after enrollment
• Not able to complete study instructions, with or without assistance, in English, Xhosa or Afrikaans
• Not willing to provide contact information
• Does not have a phone
• Identified as high-risk for HIV by the provider by meeting one or more of the criteria below:
• Have multiple partners
• Engage in transactional sex, including sex workers
• Use or abuse drugs
• Drink alcohol heavily
• Had more than 1 episode of a STI in the last year
• Is the HIV-negative partner in a discordant relationship, especially if the HIV-positive partner is not on antiretroviral therapy (ART)

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Human Sciences Research Council

Port Elizabeth, South Africa

Location

MeSH Terms

Conditions

Homosexuality

Interventions

Emtricitabine; Tenofovir; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; HIV Testing; Post-Exposure Prophylaxis

Condition Hierarchy (Ancestors)

Sexuality; Sexual Behavior; Behavior

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Drug Combinations; Pharmaceutical Preparations; Microbiological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Patrick S Sulivan, DVM, PhD

  Rollins School of Public Health

  PRINCIPAL INVESTIGATOR

• A.D. McNaghten, PhD, MHSA

  Rollins School of Public Health

  PRINCIPAL INVESTIGATOR

• Stefan Baral, MD, MPH, CCFP

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

• Nancy Phaswanamafuya, PhD

  Human Sciences Research Council

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 18, 2015
• First Posted: May 20, 2015
• Study Start: May 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: March 1, 2017
• Last Updated: July 6, 2017

Record last verified: 2017-07

Locations

ZA (1)