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Trial record 1 of 2 for:    HPTN 075
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Feasibility of HIV Prevention Cohort Studies Among Men Who Have Sex With Men in Sub-Saharan Africa

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ClinicalTrials.gov Identifier: NCT03201510
Recruitment Status : Completed
First Posted : June 28, 2017
Last Update Posted : December 3, 2018
Sponsor:
Collaborators:
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
HIV Prevention Trials Network

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).

Condition or disease Intervention/treatment
HIV 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.

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Study Type : Observational
Actual Enrollment : 401 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: HPTN 075: Feasibility of HIV Prevention Cohort Studies Among Men Who Have Sex With Men in Sub-Saharan Africa
Actual Study Start Date : June 12, 2015
Actual Primary Completion Date : August 12, 2017
Actual Study Completion Date : August 12, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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




Primary Outcome Measures :
  1. Recruitment of approximately 400 participants [ Time Frame: July 2015-July 2016 ]
    all 4 sites must collectively recruit 400 participants

  2. Retention of approximately 400 participants [ Time Frame: July 2015-July 2016 ]
    at least 90% of participants must be retained


Secondary Outcome Measures :
  1. HIV incidence [ Time Frame: July 2015-July 2017 ]
    Measured by HIV RNA from plasma samples


Biospecimen Retention:   Samples Without DNA
Plasma samples will be stored from each study visit


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03201510


Locations
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Kenya
Kisumu
Kisumu, Kenya, 40100
Malawi
Johns Hopkins Project
Blantyre, Chichiri, Malawi
South Africa
Groote Schuur
Observatory, Cape Town, South Africa, 7925
PHRU
Soweto, Gauteng, South Africa, 2193
Sponsors and Collaborators
HIV Prevention Trials Network
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Mental Health (NIMH)
Investigators
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Study Chair: Theodorus Sandfort, PhD Columbia University
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Responsible Party: HIV Prevention Trials Network
ClinicalTrials.gov Identifier: NCT03201510    
Other Study ID Numbers: HPTN 075
UM1AI068619 ( U.S. NIH Grant/Contract )
First Posted: June 28, 2017    Key Record Dates
Last Update Posted: December 3, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No