Trial record 20 of 36 for:    " January 13, 2014":" February 12, 2014"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2014 by Emory University
Sponsor:
Information provided by (Responsible Party):
Patrick S Sullivan, Emory University
ClinicalTrials.gov Identifier:
NCT02043015
First received: January 21, 2014
Last updated: May 27, 2014
Last verified: May 2014
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Comprehensive HIV Prevention Package for MSM in Southern Africa: Pilot Study

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Retention in the cohort [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.

  • Use of PrEP [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    We 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.

  • Incident HIV infection [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    This will be measured as the number of seroconversions during follow-up among those who are HIV-uninfected at baseline.


Secondary Outcome Measures:
  • Condom use [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Measured as the proportion of anal intercourse that is protected by condoms in the prior 3 months as self-reported reported in the questionnaire at each study visit.

  • Lubricant use [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Measured as the proportion of condom-protected anal intercourse in the prior for 3 months for which condom-compatible lubricant is used as self-reported in the questionnaire at each study visit.

  • VCT and CVCT uptake [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Measured as the number of times participants report HIV testing in the study period as part of the study visits and outside study visits compared to the number of time participants reported HIV testing in the year prior at baseline.

  • Serodiscordant UAI [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Measured as self-reported unprotected anal intercourse in the last 3 months with a partner of positive or unknown HIV status as self-reported in the questionnaire at each study visit, pre- and post-intervention.

  • Acceptability of PEP [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Measured as the proportion of men who report an eligible exposure who accept and initiate PEP.

  • MSM-specific provider training [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Measured as the proportion of providers who are offered training who accept the training.


Estimated Enrollment: 200
Study Start Date: May 2014
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Comprehensive HIV prevention services
A comprehensive package of HIV prevention services, including condom provision, enhanced HIV testing options, and screening for and offering of pre-exposure prophylaxis (PrEP).
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 (PrEP) 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: 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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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 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-1 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 ARV therapy (e.g., for PEP or PrEP) in the 90 days prior to study entry
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02043015

Contacts
Contact: Patrick S Sullivan, DVM, PhD 404-727-2038 pssulli@emory.edu

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 Not yet recruiting
Cape Town, South Africa
Human Sciences Research Council Not yet recruiting
Port Elizabeth, 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, CCFP Johns Hopkins School of Public Health
Principal Investigator: Linda-Gail Bekker, MBChB, PhD Desmond Tutu HIV Foundation
Principal Investigator: Nancy (Refilwe) Phaswana-Mafuya, PhD Human Sciences Research Council
Principal Investigator: Rob Stephenson, MSc, PhD Rollins School of Public Health
Principal Investigator: Chris Beyrer, MD, MPH Johns Hopkins School of Public Health
  More Information

No publications provided

Responsible Party: Patrick S Sullivan, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT02043015     History of Changes
Other Study ID Numbers: IRB00054863, MP3-1R01A1094575
Study First Received: January 21, 2014
Last Updated: May 27, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
HIV Antibodies
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014