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Phase I Trial of an Intervention to Increase Condom Use by HIV-Discordant Couples

NCT ID: NCT00000928

Last Updated: 2016-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Completion Date

1999-07-31

Brief Summary

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To assess the acceptability of and participation in a group counseling intervention, including an assessment of willingness to disclose serostatus to a regular sexual partner and the willingness of that partner to participate. To evaluate the profile of adverse experiences (social, psychological, and physical harms) of individuals resulting from participation in counseling and testing and attempts to initiate condom use within a stable HIV serodiscordant partnership. To assess the potential for the intervention to result in increased condom use among stable sexual partners.

There is a significant risk of HIV transmission to HIV-uninfected partners in HIV-discordant couples. While condom use has been a major component of most AIDS prevention programs since the mid-1980s, there has been little emphasis on promoting condom use within stable partnerships. The most effective way to promote condom use among discordant couples remains largely unknown.

Detailed Description

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There is a significant risk of HIV transmission to HIV-uninfected partners in HIV-discordant couples. While condom use has been a major component of most AIDS prevention programs since the mid-1980s, there has been little emphasis on promoting condom use within stable partnerships. The most effective way to promote condom use among discordant couples remains largely unknown.

A pilot study to assess the acceptability of intervention precedes the main study. The Phase I study recruits 15 HIV-infected men and 15 HIV-infected women and their partners at each of three sites (India, Thailand, and Uganda). Volunteers participate in a multi-session group-based condom promotion program for approximately 12 months. Couples are organized into small groups consisting of 4 to 6 couples per group. Each group meets for a total of 4 sessions within a 2- to 4-week period. Follow-up interviews are conducted at Months 1 and 3 following completion of the intervention.

Conditions

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HIV Infections

Keywords

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Sexual Partners Condoms Counseling

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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A

All study participants

Group Type EXPERIMENTAL

Group counseling intervention

Intervention Type BEHAVIORAL

Participants will engage in a multi-session group-based condom promotion program for approximately 12 months

Interventions

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Group counseling intervention

Participants will engage in a multi-session group-based condom promotion program for approximately 12 months

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

Volunteers must be:

* HIV-positive through HIVNET testing or HIV-seronegative by EIA.
* Presently in a sexual relationship of at least 6 months duration with the intention to remain with this partner for the duration of the study.
* Willing to identify and recruit this sexual partner to which he/she has disclosed or will disclose HIV serostatus.
* Willing to receive counseling and HIV testing (HIV-seronegative partners only).
* Willing to agree to be interviewed with their partner and individually.
* Willing to continue engaging in sex with their partner.
* Willing to participate in a couples-based condom promotion intervention.
* Willing and able to attend each scheduled intervention/follow-up study visit.

Exclusion Criteria

Volunteers with the following are excluded:

* History of domestic violence.
* Current consistent condom use.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David D. Celentano

Role: STUDY_CHAIR

Janet McGrath

Role: STUDY_CHAIR

Other Identifiers

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HIVNET 013

Identifier Type: -

Identifier Source: org_study_id