Comprehensive HIV Prevention Package for MSM in Southern Africa: Pilot Study (Sibanye Health Project)

NCT02043015 | Completed Results

• 2 other identifiers: IRB00054863MP3-1R01A1094575
• Study Type: interventional
• Target: 100
• Locations: 2 countries
• Sites: 3

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

  The ability of the study to retain participants for full study period was assessed. Retention was measured by the number and percentage of enrolled participants attending study visits through the 12-month study period.

  12 months

• Use of PrEP

  Uptake of PrEP by study participants was measured as the number and percentage of enrolled participants eligible for PrEP at the baseline and 3-month study visits who choose to initiate PrEP at a visit one month later.

  4 months

• Number of Participants With New HIV Infection

  Incident HIV infection is measured as the number of seroconversions during follow-up among those who are HIV-uninfected at baseline.

  12 months

Secondary Outcomes (7)

• Condom Use

  Months 3, 6, and 12

• Lubricant Use

  Months 3, 6, and 12

• Voluntary Counseling and Testing (VCT) and Couples Voluntary Counseling and Testing (CVCT) Uptake

  12 months

• Number of HIV Tests During Study

  12 months

• Serodiscordant Unprotected Anal Intercourse (UAI)

  Month 3, 6, and 12

Study Arms (1)

Comprehensive HIV prevention services

OTHER

A comprehensive package of HIV prevention services, including condom choices, Condom-compatible lubricant choices, Couples HIV counseling and testing (CVCT), Staff and provider MSM and LGBT sensitization training, HIV Testing and Risk-reduction counseling, Linkage to care, Pre-exposure prophylaxis with FTC/TDF

Behavioral: Condom choices; Behavioral: Condom-compatible lubricant choices; Behavioral: Couples HIV counseling and testing (CVCT); Drug: Pre-exposure prophylaxis with FTC/TDF; Other: Staff and provider MSM and LGBT sensitization training; Behavioral: HIV Testing and Risk-reduction counseling; Behavioral: Linkage to care

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.

Comprehensive HIV prevention services

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.

Comprehensive HIV prevention services

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.

Comprehensive HIV prevention services

Pre-exposure prophylaxis with FTC/TDF DRUG

For men who meet eligibility criteria, 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. Men who accept PrEP will be required to have clinic visits, in addition to the regularly scheduled study visits, one month after starting PrEP and at least every 3 months afterward to monitor blood creatinine, AST/ALT and phosphorus levels.

Also known as: PrEP

Comprehensive HIV prevention services

Staff and provider MSM and LGBT sensitization training OTHER

The training for clinicians will focus on specific sexual health issues for MSM, including taking sexual histories in a non-judgmental way, physical examination techniques including anal examinations, and collection of rectal swabs for STI testing. Trainings will include topics about stigma, sexual identity and coming out, anal sex, STIs, and mental health. Training on LGBT sensitization will be provided for medical providers and staff in target clinics.

Comprehensive HIV prevention services

HIV Testing and 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.

Comprehensive HIV prevention services

Linkage to care BEHAVIORAL

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 STIs will be treated at the clinic site.

Comprehensive HIV prevention services

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
• 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 (3)

Rollins School of Public Health

Atlanta, Georgia, 30322, United States

Location

Johns Hopkins School of Public Health

Baltimore, Maryland, 21205, United States

Location

Desmond Tutu HIV Foundation

Cape Town, South Africa

Location

Related Publications (1)

• McNaghten A, Kearns R, Siegler AJ, Phaswana-Mafuya N, Bekker LG, Stephenson R, Baral SD, Brookmeyer R, Yah CS, Lambert AJ, Brown B, Rosenberg E, Blalock Tharp M, de Voux A, Beyrer C, Sullivan PS. Sibanye Methods for Prevention Packages Program Project Protocol: Pilot Study of HIV Prevention Interventions for Men Who Have Sex With Men in South Africa. JMIR Res Protoc. 2014 Oct 16;3(4):e55. doi: 10.2196/resprot.3737.

  PMID: 25325296 DERIVED

MeSH Terms

Conditions

Homosexuality

Interventions

Pre-Exposure Prophylaxis; HIV Testing

Condition Hierarchy (Ancestors)

Sexuality; Sexual Behavior; Behavior

Intervention Hierarchy (Ancestors)

Primary Prevention; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Public Health Practice; Public Health; Environment and Public Health; Microbiological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Results Point of Contact

• Title: Patrick S Sullivan PhD/DVM
• Organization: Emory University

pssulli@emory.edu

404-727-2038

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

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

• Linda-Gail Bekker, MBChB, PhD

  Desmond Tutu HIV Foundation

  PRINCIPAL INVESTIGATOR

• Rob Stephenson, MSc, PhD

  Rollins School of Public Health

  PRINCIPAL INVESTIGATOR

• Chris Beyrer, MD, MPH

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: January 21, 2014
• First Posted: January 23, 2014
• Study Start: February 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: March 1, 2017
• Last Updated: September 17, 2018
• Results First Posted: January 17, 2018

Record last verified: 2018-09

Locations

US (2); ZA (1)