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

NCT03201510 | Completed DMC

• 2 other identifiers: HPTN 075UM1AI068619
• Study Type: observational
• Target: 401
• Locations: 3 countries
• Sites: 4

Brief Summary

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).

Conditions

HIV

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• HIV incidence

  July 2015-July 2017

Study Arms (1)

Observational

Observational study

Other: Observational

Interventions

Observational OTHER

HPTN 075 is an observational study in sub-Saharan MSM

Observational

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• Biologically male at birth, according to self-report;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• HIV Prevention Trials Network: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (4)

Kisumu

Kisumu, 40100, Kenya

Location

Johns Hopkins Project

Blantyre, Chichiri, Malawi

Location

Groote Schuur

Observatory, Cape Town, 7925, South Africa

Location

PHRU

Soweto, Gauteng, 2193, South Africa

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma samples will be stored from each study visit

MeSH Terms

Interventions

Watchful Waiting

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Theodorus Sandfort, PhD

  Columbia University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2017
• First Posted: June 28, 2017
• Study Start: June 12, 2015
• Primary Completion: August 12, 2017
• Study Completion: August 12, 2017
• Last Updated: March 27, 2025

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (2); MA (1); KE (1)