HIVHPTN063NCT01264185
Preparing for International Prevention Trials Involving HIV-Infected Individuals in Care Settings
An observational study of HIV, run by HIV Prevention Trials Network at 3 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV
- How many people
- 751 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Apr 2010to Aug 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Brazil1 site
Instituto de Pesquisa Clinicaq Evandro Chagas CRS
Manguinhos, Rio de Janeiro, 221045-900
About this study
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
- HIV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Asia--Thailand; S. America--Brazil | Not described | |
| Africa--Zambia | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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
Measured: 1 year
Secondary outcomes (1)
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2010 (estimated)
- Study startApr 2010
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 751 participants (actual)
Sponsor and investigators
- Lead sponsor
- HIV Prevention Trials Network
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Steve Safren, PhD, Study chair, Fenway Community Health CenterKen Mayer, MD, Study chair, Fenway Community Health CenterStewart Reid, MD, MPH, Principal investigator, Centre for Infectious Disease Research in ZambiaRuth 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01264185
- Sponsor's protocol ID
- HPTN 063
- Acronym
- HPTN063
- Status last verified
- Aug 2022
- First submitted
- 14 Dec 2010
- Last updated
- 26 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preparing for International Prevention Trials Involving HIV-Infected Individuals in Care Settings
- ClinicalTrials.gov ID
- NCT01264185
- Acronym / sponsor ID
- HPTN063 / HPTN 063
- Conditions
- HIV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 751 participants (actual)
- Lead sponsor
- HIV Prevention Trials NetworkResearch network
- Study start
- Apr 2010
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 21 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Asia--Thailand; S. America--Brazil | – | – |
| Africa--Zambia | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Establish baseline rates of sexual HIV transmission risk
Time frame: 1 year
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
Structure and content of a behavioral intervention for individuals with HIV
Time frame: 1 year
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.
Identify psychosocial and sociodemographic correlates of sexual risk-taking
Time frame: 1 year
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 secondary outcome
Determine sexually transmitted infection(STI)prevalence and incidence
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV, run by HIV Prevention Trials Network at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Brazil, Thailand, Zambia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establish baseline rates of sexual HIV transmission risk (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2022.