CompletedNCT01264185HPTN063Updated Aug 26, 2022

Preparing for International Prevention Trials Involving HIV-Infected Individuals in Care Settings

An observational study in HIV, sponsored by HIV Prevention Trials Network. Completed at 3 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-26.

Sponsored by HIV Prevention Trials Network · Observational

Study type: Observational
Model: Cohort
Time perspective: Prospective
Enrollment: 751
Ages: 18 Years and older
Sex: All

Study summary

The purpose of this study is to conduct preparatory research needed to design a behavioral intervention to decrease sexual transmission risk behaviors in HIV-infected individuals in care and to determine whether a similar intervention structure can be used across various sexual risk groups and cultural settings.

Conditions studied

In context

Lead sponsor

HIV Prevention Trials Network is the lead sponsor of 24 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Non-probability sample

Study population

Asia (Thailand) and South America (Brazil)

100 heterosexual men,
100 heterosexual women,
100 Men having sex with men (MSM), and
\~40 community members and stakeholders

Africa (Zambia)

100 heterosexual men,
100 heterosexual women,
\~40 community members and stakeholders

Inclusion criteria

Men and women at least 18 years of age (Note: Pregnant and breast feeding women are allowed to enroll into the study)
Documented evidence of HIV infection (HIV diagnosis performed outside of the trial is acceptable so long as local/country guidelines were followed in the testing)
Receiving HIV/AIDS care (defined as at least two visits within 9 months of enrollment) in a formal health care setting (clinic or hospital)
Reported history of sexual risk behavior in the previous 12 months, including: acquisition of a sexually transmitted infection, vaginal or anal intercourse without a condom, difficulty negotiating condom use, or non-disclosure of HIV status to an HIV-uninfected partner or partner of unknown HIV serostatus.
NOTE: For the MSM population, we will enroll men who have sex with men, regardless of whether or not they also have sex with women

Exclusion criteria

Exclusion Criteria:

Anyone currently enrolled in another study that involves protocolized HIV risk reduction counseling (e.g. ACTG 5175 or HPTN 052) or any other prevention study
Anyone having unprotected (i.e. without a condom) sex for the expressed purpose of conceiving
Planning to relocate out of the area in the next year
Any condition that, in the opinion of the Investigator of Record or designee, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives

Study design

Observational model: Cohort
Time perspective: Prospective
Enrollment: 751 participants (actual)
Biospecimen retention: Samples with dna

Groups and cohorts

Asia--Thailand; S. America--Brazil
Africa--Zambia

What researchers measure

Primary outcomes

Establish baseline rates of sexual HIV transmission risk
To establish baseline rates of sexual HIV transmission risk behavior in high risk HIV-infected individuals, and to observe the rates and patterns of behavior change over time
Time frame: 1 year
Structure and content of a behavioral intervention for individuals with HIV
To gather formative data on the potential structure and content of a behavioral intervention for individuals with HIV in care in international settings and to determine the best, culturally appropriate model for the intervention that will link prevention to care for HIV-infected individuals.
Time frame: 1 year
Identify psychosocial and sociodemographic correlates of sexual risk-taking
To examine potential psychosocial and sociodemographic correlates of sexual risk-taking in these individuals in order to help shape the content of an individualized behavioral intervention
Time frame: 1 year

Secondary outcomes

Determine sexually transmitted infection(STI)prevalence and incidence
Evaluate STI prevalence and incidence and investigate whether these biomarkers may be used to corroborate self-reported sexual behavior associated with potential transmission risks
Time frame: 1 year

Study locations

3 sites

Instituto de Pesquisa Clinicaq Evandro Chagas CRS
Manguinhos, RJ 221045-900, Brazil
Chiang Mai University AIDS CRS
Chiang Mai, Thailand
Matero Reference Clinic
Lusaka, Zambia

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 26, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01264185
Lead sponsor: HIV Prevention Trials Network
Responsible party: Sponsor
First posted: Dec 21, 2010
Start date: Apr 2010
Primary completion: Aug 2014
Completion: Aug 2014
Last update: Aug 26, 2022

Study contacts

Steve Safren, PhD

study chair · Fenway Community Health Center

Ken Mayer, MD

study chair · Fenway Community Health Center

Stewart Reid, MD, MPH

principal investigator · Centre for Infectious Disease Research in Zambia (CIDRZ)

Ruth Friedman, MD

principal investigator · Instituto de Pesquisa Clincia Evandro Chagas (IPEC) Clinical Research Site (CRS)

Kriengkrai Srithanaviboonchai, MD, MPH

principal investigator · Chiang Mai University AIDS CRS

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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