Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03201510
Other study ID # HPTN 075
Secondary ID UM1AI068619
Status Completed
Phase
First received
Last updated
Start date June 12, 2015
Est. completion date August 12, 2017

Study information

Verified date November 2018
Source HIV Prevention Trials Network
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 401
Est. completion date August 12, 2017
Est. primary completion date August 12, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 44 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Observational
HPTN 075 is an observational study in sub-Saharan MSM

Locations

Country Name City State
Kenya Kisumu Kisumu
Malawi Johns Hopkins Project Blantyre Chichiri
South Africa Groote Schuur Observatory Cape Town
South Africa PHRU Soweto Gauteng

Sponsors (3)

Lead Sponsor Collaborator
HIV Prevention Trials Network National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Mental Health (NIMH)

Countries where clinical trial is conducted

Kenya,  Malawi,  South Africa, 

Outcome

Type Measure Description Time frame Safety issue
Primary Recruitment of approximately 400 participants all 4 sites must collectively recruit 400 participants July 2015-July 2016
Primary Retention of approximately 400 participants at least 90% of participants must be retained July 2015-July 2016
Secondary HIV incidence Measured by HIV RNA from plasma samples July 2015-July 2017
See also
  Status Clinical Trial Phase
Recruiting NCT06162897 - Case Management Dyad N/A
Completed NCT03999411 - Smartphone Intervention for Smoking Cessation and Improving Adherence to Treatment Among HIV Patients Phase 4
Completed NCT02528773 - Efficacy of ART to Interrupt HIV Transmission Networks
Recruiting NCT05454839 - Preferences for Services in a Patient's First Six Months on Antiretroviral Therapy for HIV in South Africa
Recruiting NCT05322629 - Stepped Care to Optimize PrEP Effectiveness in Pregnant and Postpartum Women N/A
Completed NCT02579135 - Reducing HIV Risk Among Adolescents: Evaluating Project HEART N/A
Active, not recruiting NCT01790373 - Evaluating a Youth-Focused Economic Empowerment Approach to HIV Treatment Adherence N/A
Not yet recruiting NCT06044792 - The Influence of Primary HIV-1 Drug Resistance Mutations on Immune Reconstruction in PLWH
Completed NCT04039217 - Antiretroviral Therapy (ART) Persistence in Different Body Compartments in HIV Negative MSM Phase 4
Active, not recruiting NCT04519970 - Clinical Opportunities and Management to Exploit Biktarvy as Asynchronous Connection Key (COMEBACK) N/A
Completed NCT04124536 - Combination Partner HIV Testing Strategies for HIV-positive and HIV-negative Pregnant Women N/A
Recruiting NCT05599581 - Tu'Washindi RCT: Adolescent Girls in Kenya Taking Control of Their Health N/A
Active, not recruiting NCT04588883 - Strengthening Families Living With HIV in Kenya N/A
Completed NCT02758093 - Speed of Processing Training in Adults With HIV N/A
Completed NCT02500446 - Dolutegravir Impact on Residual Replication Phase 4
Completed NCT03805451 - Life Steps for PrEP for Youth N/A
Active, not recruiting NCT03902431 - Translating the ABCS Into HIV Care N/A
Completed NCT00729391 - Women-Focused HIV Prevention in the Western Cape Phase 2/Phase 3
Recruiting NCT05736588 - Elimisha HPV (Human Papillomavirus) N/A
Recruiting NCT03589040 - Darunavir and Rilpivirine Interactions With Etonogestrel Contraceptive Implant Phase 2