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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03201510
• Date of registration: 26/06/2017
• Prospective Registration: No
• Primary sponsor: HIV Prevention Trials Network
• Public title: Feasibility of HIV Prevention Cohort Studies Among Men Who Have Sex With Men in Sub-Saharan Africa
• Scientific title: HPTN 075: Feasibility of HIV Prevention Cohort Studies Among Men Who Have Sex With Men in Sub-Saharan Africa
• Date of first enrolment: June 12, 2015
• Target sample size: 401
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03201510
• Study type: Observational

Countries of recruitment

Kenya, Malawi, South Africa

Contacts

• Name: Theodorus Sandfort, PhD
• Affiliation: Columbia University

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 44 Years
Gender: Male

Health Condition(s) or Problem(s) studied

HIV

Intervention(s)

Other: Observational

Primary Outcome(s)

Retention of approximately 400 participants [Time Frame: July 2015-July 2016]

Recruitment of approximately 400 participants [Time Frame: July 2015-July 2016]

Secondary Outcome(s)

HIV incidence [Time Frame: July 2015-July 2017]

Secondary ID(s)

UM1AI068619

HPTN 075

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Institute of Mental Health (NIMH)

National Institute of Allergy and Infectious Diseases (NIAID)