Feasibility of HIV Prevention Cohort Studies Among Men Who Have Sex With Men in Sub-Saharan Africa

HPTN 075: Feasibility of HIV Prevention Cohort Studies Among Men Who Have Sex With Men in Sub-Saharan Africa

This study aims to determine the feasibility of recruiting and retaining men who have sex with men (MSM) in a multi-country prospective cohort study in preparation for human immunodeficiency virus (HIV) prevention studies in sub-Saharan Africa (SSA).

Study Overview

• Status: Completed
• Conditions: HIV
• Intervention / Treatment: Other: Observational

Detailed Description

HPTN 075 is an observational cohort study. Participants will be accrued over six months at four sites in SSA using convenience sampling strategies, with no replacement for participants lost to follow-up. Each participant will be followed for 12 months, during which five study visits involving structured HIV behavioral assessments, medical examinations, and collection of biological samples will be conducted (including enrollment and quarterly follow-up visits). Participants who do not complete 12 months of follow-up will be contacted to explore reasons for no longer participating.

• Study Type: Observational
• Enrollment (Actual): 401

Contacts and Locations

Study Locations

• Kenya
  • Kisumu, Kenya, 40100
    • Kisumu
• Malawi
  • Chichiri
    • Blantyre, Chichiri, Malawi
      • Johns Hopkins Project
• South Africa
  • Cape Town
    • Observatory, Cape Town, South Africa, 7925
      • Groote Schuur
  • Gauteng
    • Soweto, Gauteng, South Africa, 2193
      • PHRU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 44 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Men, regardless of HIV infection status, aged 18-44 years living in SSA who report anal sex with a man in the past 3 months.

Description

Inclusion Criteria:

• Biologically male at birth, according to self-report;
• 18-44 years old (inclusive);
• Willing and able to provide informed consent;
• Willing to undergo HIV testing throughout the study and to receive those test results;
• Reporting at least one act of anal intercourse in the previous 3 months (12 weeks) with a person reported by the participant to be biologically male;
• Able to provide complete locator identification for themselves and at least two other personal contacts;
• Willing to participate in all scheduled study assessments, including specimen collection, laboratory assessments, and sample storage;
• Committing to not participate in any HIV intervention or vaccine study while participating in HPTN 075;
• Planning to remain in the study area for at least one year;
• For HIV-uninfected men: All HIV test results at the Screening visit must be non-reactive/negative;
• For HIV-infected men (up to 20 per site): All HIV test results at the Screening visit must be reactive/positive.

Men who are already on PrEP will not be excluded. Additionally, self- or other-identified transgender women and male sex workers will not be excluded. There will, however, be no specific effort to recruit these groups.

Exclusion Criteria:

• Unwilling to adhere to study procedures;
• Past or current participation in a biomedical and/or behavioral HIV/STI intervention or cohort study, including HIV vaccine studies; however, participation in local/area PrEP demonstration projects does not preclude participation in HPTN 075;
• HIV-infected men who report that they are already on ART or in HIV care;
• Any other reason or condition that in the opinion of the Investigator of Record (IOR) would interfere with participation, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
• Men who have discordant HIV test results at Screening (i.e., at least one reactive or positive result and at least one non-reactive or negative result). These men will receive HIV counseling and will be referred for further diagnostic tests and care.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Observational; Observational study	Other: Observational; HPTN 075 is an observational study in sub-Saharan MSM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment of approximately 400 participants	all 4 sites must collectively recruit 400 participants	July 2015-July 2016
Retention of approximately 400 participants	at least 90% of participants must be retained	July 2015-July 2016

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HIV incidence	Measured by HIV RNA from plasma samples	July 2015-July 2017

Collaborators and Investigators

• Sponsor: HIV Prevention Trials Network
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID); National Institute of Mental Health (NIMH)
• Investigators: Study Chair: Theodorus Sandfort, PhD, Columbia University

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2015
• Primary Completion (Actual): August 12, 2017
• Study Completion (Actual): August 12, 2017

Study Registration Dates

• First Submitted: June 26, 2017
• First Submitted That Met QC Criteria: June 26, 2017
• First Posted (Actual): June 28, 2017

Study Record Updates

• Last Update Posted (Actual): December 3, 2018
• Last Update Submitted That Met QC Criteria: November 30, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: HPTN 075; UM1AI068619 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO