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

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ClinicalTrials.gov Identifier: NCT02043015
Recruitment Status : Completed
First Posted : January 23, 2014
Results First Posted : January 17, 2018
Last Update Posted : January 17, 2018
Sponsor:
Information provided by (Responsible Party):
Patrick S Sullivan, Emory University

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.

Condition or disease Intervention/treatment
HIV 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

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Comprehensive HIV Prevention Package for MSM in Southern Africa: Pilot Study
Actual Study Start Date : February 2015
Primary Completion Date : October 2016
Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arm Intervention/treatment
Comprehensive HIV prevention services
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
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: Pre-exposure prophylaxis with FTC/TDF
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.
Other Name: PrEP
Other: Staff and provider MSM and LGBT sensitization training
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.
Behavioral: HIV Testing and 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.
Behavioral: 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 STIs will be treated at the clinic site.



Primary Outcome Measures :
  1. Retention in the Cohort [ Time Frame: 12 months ]
    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.

  2. Use of PrEP [ Time Frame: 4 months ]
    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.

  3. Number of Participants With New HIV Infection [ Time Frame: 12 months ]
    Incident HIV infection is measured as the number of seroconversions during follow-up among those who are HIV-uninfected at baseline.


Secondary Outcome Measures :
  1. Condom Use [ Time Frame: Months 3, 6, and 12 ]
    Condom use is measured as the number of male anal sex partners that the study participant always used condoms with in the prior three or six months, as self-reported reported in the questionnaire at each study visit.

  2. Lubricant Use [ Time Frame: Months 3, 6, and 12 ]
    Measured as the number and percentage of participants who used condom-compatible lubricant during their most recent anal sex act, among those who also used a condom at their most recent anal sex act.

  3. Voluntary Counseling and Testing (VCT) and Couples Voluntary Counseling and Testing (CVCT) Uptake [ Time Frame: 12 months ]
    VCT and CVCT is measured as the number and percentage of participants who completed VCT in the study period as part of the study visits and the number and percentage of participants who self-reported VCT outside of their study visits. These are compared to the number and percentage of participants who self-reported having VCT in the year prior at baseline. CVCT is measured as the number and percentage of participants who completed a CVCT session as part of the study.

  4. Number of HIV Tests During Study [ Time Frame: 12 months ]
    The number of HIV tests per participant administered during the study period.

  5. Serodiscordant Unprotected Anal Intercourse (UAI) [ Time Frame: Month 3, 6, and 12 ]
    Measured as any self-reported unprotected anal intercourse in the last three or six months with a partner of opposite or unknown HIV status, as self-reported in the questionnaire at each study visit.

  6. Acceptability of Post-exposure Prophylaxis (PEP) [ Time Frame: 12 months ]
    Measured as the number of men who report an eligible exposure who accept and initiate PEP.

  7. Acceptability of Provider Training [ Time Frame: 12 months ]
    Measured as the number of providers who accept the training related to MSM-specific healthcare.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male sex at birth
  • Anal sex with another man in the past 12 months
  • 18 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

Exclusion Criteria:

  • 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

Additional Inclusion and Exclusion Criteria for participants on PrEP:

PrEP Inclusion Criteria:

  • 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)
  • Is in a non-monogamous concordant relationship with a HIV-negative partner
  • Is unable or unwilling to achieve consistent use of male condoms
  • No contra-indications to Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)
  • Calculated creatinine clearance of at least 60 mL/min
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2 x upper limit of normal (ULN)
  • Hepatitis B surface antigen (HBsAg) negative
  • Motivated to follow PrEP prescribing guidelines
  • Willing to adhere to daily oral dosing
  • Willing to attend PrEP maintenance visits every 3 months

PrEP Exclusion Criteria:

  • HIV positive
  • Signs or symptoms suggestive of acute HIV infection
  • Have baseline creatinine clearance <60 ml/min
  • Are unwilling to follow PrEP prescribing guidelines
  • Are unwilling to attend PrEP maintenance visits every 3 months
  • Are known to have hypertensives or diabetes
  • Are hepatitis B susceptible (test HBsAg and HBsAb negative) and refuse to take a hepatitis B vaccine series
  • Any contraindication to taking FTC/TDF
  • Proteinuria 2+ or greater at screening
  • Glucosuria 2+ or greater at screening
  • Use of antiretroviral (ARV) therapy (e.g., for PEP or PrEP) in the 90 days prior to study entry

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02043015


Locations
United States, Georgia
Rollins School of Public Health
Atlanta, Georgia, United States, 30322
United States, Maryland
Johns Hopkins School of Public Health
Baltimore, Maryland, United States, 21205
South Africa
Desmond Tutu HIV Foundation
Cape Town, South Africa
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: 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 Centre
Principal Investigator: Rob Stephenson, MSc, PhD Rollins School of Public Health
Principal Investigator: Chris Beyrer, MD, MPH Johns Hopkins Bloomberg School of Public Health

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Patrick S Sullivan, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT02043015     History of Changes
Other Study ID Numbers: IRB00054863
MP3-1R01A1094575 ( Other Identifier: Other )
First Posted: January 23, 2014    Key Record Dates
Results First Posted: January 17, 2018
Last Update Posted: January 17, 2018
Last Verified: December 2017

Keywords provided by Patrick S Sullivan, Emory University:
voluntary counseling and testing (VCT)
couples voluntary counseling and testing (CVCT)
pre-exposure prophylaxis (PrEP)
homosexuality
male
South Africa