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

HIV Clinical Trial

— HPTN063  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01264185
• Other study ID #: HPTN 063
• Status: Completed
• Start date: April 2010
• Est. completion date: August 2014

Study information

• Verified date: August 2022
• Source: HIV Prevention Trials Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 751
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

• 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

Related Conditions & MeSH terms

• HIV

Locations

Country	Name	City	State
Brazil	Instituto de Pesquisa Clinicaq Evandro Chagas CRS	Manguinhos	RJ
Thailand	Chiang Mai University AIDS CRS	Chiang Mai
Zambia	Matero Reference Clinic	Lusaka

Sponsors (1)

Lead Sponsor	Collaborator
HIV Prevention Trials Network

Countries where clinical trial is conducted

Brazil,  Thailand,  Zambia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 year
Primary	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.	1 year
Primary	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	1 year
Secondary	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	1 year