HIVNCT03201510
Feasibility of HIV Prevention Cohort Studies Among Men Who Have Sex With Men in Sub-Saharan Africa
An observational study of HIV, run by HIV Prevention Trials Network at 4 sites in 3 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 44 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- Observational
- How many people
- 401 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 12 Jun 2015to 12 Aug 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- Men only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
South Africa2 sites
Groote Schuur
Observatory, Cape Town, 7925
PHRU
Soweto, Gauteng, 2193
About this study
Official title: 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).
Read the 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.
- Conditions
- HIV
- Being tested
- Observational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
HPTN 075 is an observational study in sub-Saharan MSM
| Study group | Role | What they receive |
|---|---|---|
| Observational | Observational study Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment of approximately 400 participants
all 4 sites must collectively recruit 400 participants
Measured: July 2015-July 2016
Retention of approximately 400 participants
at least 90% of participants must be retained
Measured: July 2015-July 2016
Secondary outcomes (1)
HIV incidence
Measured by HIV RNA from plasma samples
Measured: July 2015-July 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2017
- Study start12 Jun 2015
- Primary completion12 Aug 2017
- Study completion12 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 401 participants (actual)
Sponsor and investigators
- Lead sponsor
- HIV Prevention Trials Network
- Sponsor type
- Research network
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Theodorus Sandfort, PhD, Study chair, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03201510
- Sponsor's protocol ID
- HPTN 075
- Other IDs
- UM1AI068619
- Status last verified
- Aug 2022
- First submitted
- 26 Jun 2017
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HPTN 075: Feasibility of HIV Prevention Cohort Studies Among Men Who Have Sex With Men in Sub-Saharan Africa
- ClinicalTrials.gov ID
- NCT03201510
- Acronym / sponsor ID
- HPTN 075
- Conditions
- HIV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 401 participants (actual)
- Lead sponsor
- HIV Prevention Trials NetworkResearch network
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Mental Health (NIMH)
- Study start
- 12 Jun 2015 (actual)
- Primary completion
- 12 Aug 2017 (actual)
- Study completion
- 12 Aug 2017 (actual)
- First posted
- 28 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | Other: ObservationalObservational study |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (12 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationalHPTN 075 is an observational study in sub-Saharan MSM | Other | Observational |
Primary outcome
Recruitment of approximately 400 participants
Time frame: July 2015-July 2016
all 4 sites must collectively recruit 400 participants
Retention of approximately 400 participants
Time frame: July 2015-July 2016
at least 90% of participants must be retained
1 secondary outcome
HIV incidence
Time frame: July 2015-July 2017
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Theodorus Sandfort, PhD study chair
Columbia University
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV, run by HIV Prevention Trials Network at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in South Africa, Kenya, Malawi. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment of approximately 400 participants (time frame: July 2015-July 2016). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025.