Acquired Immunodeficiency SyndromePhase 2NCT00325585
HIV Prevention Intervention for Couples
A Phase 2 study testing Couples HIV counseling and testing and Women's relationship-focused HIV counseling and testing in people with Acquired Immunodeficiency Syndrome, run by National Development and Research Institutes, Inc. at 1 site in United States.
Trial summary
Recent studies have shown that many drug-using minority women are vulnerable to HIV infection from their husbands or other intimate male partners. The goal of this study is to develop and evaluate two new HIV counseling and testing programs designed for drug-using women at risk for HIV from a primary male partner. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acquired Immunodeficiency Syndrome
- What is being tested?
- Couples HIV counseling and testing and Women's relationship-focused HIV counseling and testing
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 780 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2005to Jun 2008
- Phase
- Phase 2
- 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
Who may be able to join
- For women:
- 18 years of age or older
- self-reported use of crack, cocaine or heroin in prior 30 days
- has male sex partner identified as primary partner for at least one year
- had unprotected vaginal or anal sex with current partner in prior 30 days
- able to enlist partner in study enrollment
Show all 11Show fewer
- would not feel threatened participating in the study with primary partner
- must not have participated in HIV/AIDS related study or attended HIV counseling and testing session in six months
- self-reported HIV negative or sero-unaware
- For men:
- 18 years of age or older
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
NDRI South Bronx Field Office
The Bronx, New York, 10455
About this study
Official title: Couples HIV Intervention Randomized Controlled Trial
Recent studies have shown that many drug-using minority women are vulnerable to HIV infection from their husbands or other intimate male partners. The goal of this study is to develop and evaluate two new HIV counseling and testing programs designed for drug-using women at risk for HIV from a primary male partner. It is predicted that HIV counseling and testing programs administered to couples rather than to women only, and programs that focus on intimate relationships in the context of HIV risk, will result in a reduction of risky sexual and drug-related behavior among drug-using women and their primary male partners. This four-year study employs a randomized clinical trial (RCT) design to test the effectiveness of two new HIV counseling and testing programs for women drug-users in Harlem and the South Bronx in New York City.
Read the detailed description
The broad, long-term objective of this research is to establish primary preventive interventions to reduce human immunodeficiency virus (HIV) risk behavior among drug-using minority women. Recent studies indicate that high rates of sexual risk behavior occur within drug-using minority women's primary heterosexual relationships. Based on an integrated theory of HIV risk behavior, it is predicted that (a) interventions administered to couples rather than to women only, and (b) interventions that focus on relationship dynamics in the context of HIV risk, will result in a reduction of sexual and drug-related risk behavior among drug-using women and their primary partners. This four-year study employs a randomized clinical trial (RCT) 3-group design to test the efficacy of HIV intervention modality (couples versus women-only) and intervention content (relationship-focused versus standard HIV counseling and testing) on crack, cocaine and heroin (injected and noninjected) using women's sexual risk with primary partners.
A total of 390 women drug-users and their partners are recruited from the streets of Harlem and the South Bronx in New York City. Participants are randomly assigned to one of three HIV counseling and testing intervention conditions: (a) couples, relationship-focused; (b) women-only, relationship-focused; or, (c) NIDA women-only standard HIV-CT (control). All subjects are administered baseline, 3-month, and 9-month follow-up assessments using a combination of computer-assisted personal interview (CAPI) and computer-assisted self interview (CASI) techniques. In addition to sociodemographic characteristics, the interview will measure drug-use patterns, HIV risk behavior, and dyadic- and individual-level variables operationalized to test specific hypotheses of women's HIV risk behavior and behavior change. In addition to testing the effectiveness of the experimental interventions, data analyses will determine the theory-driven psychosocial mechanisms that act to mediate and moderate any observed association between intervention treatment and subsequent risk reduction. Incremental cost-effectiveness analyses will also be performed.
Results from this study will allow researchers to determine whether couple-based HIV counseling and testing is a more effective (and cost-effective) approach to HIV prevention than individual HIV counseling and testing. Analyses will further provide information on the specific components of couple-based interventions that were most effective in reducing HIV risk behavior, thereby contributing to theory development regarding intimate couples' HIV risk.
- Conditions
- Acquired Immunodeficiency Syndrome
- Being tested
- Couples HIV counseling and testing, Women's relationship-focused HIV counseling and testing
- Keywords
- Human Immunodeficiency Viruses, Acquired Immunodeficiency Syndrome, Substance Abuse, Sexually Transmitted Disease, Viral, Intervention Studies, Women's Health
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Substance-Related Disorders, Sexually Transmitted Diseases, Viral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Couples HIV counseling and testingBehavioural
Women's relationship-focused HIV counseling and testingBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
risk behaviors
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2006 (estimated)
- Study startApr 2005
- Primary completionDec 2007
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired Immunodeficiency SyndromeStudies 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
- Interventional
- Phase
- Phase 2
- Enrolment
- 780 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Development and Research Institutes, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- James M McMahon, Ph.D., Principal investigator, National Development and Research Institutes, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00325585
- Sponsor's protocol ID
- R01DA015641
- Other IDs
- R01DA015641
- Status last verified
- Apr 2013
- First submitted
- 11 May 2006
- Last updated
- 9 Apr 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Couples HIV Intervention Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00325585
- Acronym / sponsor ID
- R01DA015641
- Conditions
- Acquired Immunodeficiency Syndrome
- Keywords
- Human Immunodeficiency Viruses, Acquired Immunodeficiency Syndrome, Substance Abuse, Sexually Transmitted Disease, Viral, Intervention Studies, Women's Health
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 780 participants (estimated)
- Lead sponsor
- National Development and Research Institutes, Inc.University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Apr 2005
- Primary completion
- Dec 2007 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 15 May 2006 (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.
Recent studies have shown that many drug-using minority women are vulnerable to HIV infection from their husbands or other intimate male partners. The goal of this study is to develop and evaluate two new HIV counseling and testing programs designed for drug-using women at risk for HIV from a primary male partner. It is predicted that HIV counseling and testing programs administered to couples rather than to women only, and programs that focus on intimate relationships in the context of HIV risk, will result in a reduction of risky sexual and drug-related behavior among drug-using women and their primary male partners. This four-year study employs a randomized clinical trial (RCT) design to test the effectiveness of two new HIV counseling and testing programs for women drug-users in Harlem and the South Bronx in New York City.
Detailed description
The broad, long-term objective of this research is to establish primary preventive interventions to reduce human immunodeficiency virus (HIV) risk behavior among drug-using minority women. Recent studies indicate that high rates of sexual risk behavior occur within drug-using minority women's primary heterosexual relationships. Based on an integrated theory of HIV risk behavior, it is predicted that (a) interventions administered to couples rather than to women only, and (b) interventions that focus on relationship dynamics in the context of HIV risk, will result in a reduction of sexual and drug-related risk behavior among drug-using women and their primary partners. This four-year study employs a randomized clinical trial (RCT) 3-group design to test the efficacy of HIV intervention modality (couples versus women-only) and intervention content (relationship-focused versus standard HIV counseling and testing) on crack, cocaine and heroin (injected and noninjected) using women's sexual risk with primary partners.
A total of 390 women drug-users and their partners are recruited from the streets of Harlem and the South Bronx in New York City. Participants are randomly assigned to one of three HIV counseling and testing intervention conditions: (a) couples, relationship-focused; (b) women-only, relationship-focused; or, (c) NIDA women-only standard HIV-CT (control). All subjects are administered baseline, 3-month, and 9-month follow-up assessments using a combination of computer-assisted personal interview (CAPI) and computer-assisted self interview (CASI) techniques. In addition to sociodemographic characteristics, the interview will measure drug-use patterns, HIV risk behavior, and dyadic- and individual-level variables operationalized to test specific hypotheses of women's HIV risk behavior and behavior change. In addition to testing the effectiveness of the experimental interventions, data analyses will determine the theory-driven psychosocial mechanisms that act to mediate and moderate any observed association between intervention treatment and subsequent risk reduction. Incremental cost-effectiveness analyses will also be performed.
Results from this study will allow researchers to determine whether couple-based HIV counseling and testing is a more effective (and cost-effective) approach to HIV prevention than individual HIV counseling and testing. Analyses will further provide information on the specific components of couple-based interventions that were most effective in reducing HIV risk behavior, thereby contributing to theory development regarding intimate couples' HIV risk.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 18 years of age or older
- self-reported use of crack, cocaine or heroin in prior 30 days
- has male sex partner identified as primary partner for at least one year
- had unprotected vaginal or anal sex with current partner in prior 30 days
- able to enlist partner in study enrollment
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Couples HIV counseling and testing | Behavioural | – |
| Women's relationship-focused HIV counseling and testing | Behavioural | – |
Primary outcome
risk behaviors
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 9 Apr 2013.
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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.
James M McMahon, Ph.D. principal investigator
National Development and Research Institutes, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Couples HIV counseling and testing and Women's relationship-focused HIV counseling and testing in people with Acquired Immunodeficiency Syndrome, run by National Development and Research Institutes, Inc. at 1 site in United States.
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 11 inclusion and 0 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 9 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
risk behaviors. 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 9 Apr 2013.