Clinical trial NCT01264185: Preparing for International Prevention Trials Involving HIV-Infected Individuals in Care Settings
Official title: Preparing for International Prevention Trials Involving HIV-Infected Individuals in Care Settings
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV
Lead sponsor: HIV Prevention Trials Network
Sponsor class: NETWORK
First posted: 2010-12-21
Enrollment: 751
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Establish baseline rates of sexual HIV transmission risk
timeFrame: 1 year
measure: Structure and content of a behavioral intervention for individuals with HIV
timeFrame: 1 year
measure: Identify psychosocial and sociodemographic correlates of sexual risk-taking
timeFrame: 1 year
Secondary outcomes:
measure: Determine sexually transmitted infection(STI)prevalence and incidence
timeFrame: 1 year
Other outcomes:
Locations:
city: Manguinhos
country: Brazil
facility: Instituto de Pesquisa Clinicaq Evandro Chagas CRS
state: RJ
city: Chiang Mai
country: Thailand
facility: Chiang Mai University AIDS CRS
city: Lusaka
country: Zambia
facility: Matero Reference Clinic
Study officials:
affiliation: Fenway Community Health Center
name: Steve Safren, PhD
role: STUDY_CHAIR
affiliation: Fenway Community Health Center
name: Ken Mayer, MD
role: STUDY_CHAIR
affiliation: Centre for Infectious Disease Research in Zambia (CIDRZ)
name: Stewart Reid, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto de Pesquisa Clincia Evandro Chagas (IPEC) Clinical Research Site (CRS)
name: Ruth Friedman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chiang Mai University AIDS CRS
name: Kriengkrai Srithanaviboonchai, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: