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OpenTrials
Completed

NCT Number: NCT04766697

SAVA Syndemic Risk Reduction for African American Couples

Synergistic interactions among substance abuse, violence, and HIV/AIDS, dubbed the SAVA syndemic, are highly linked to HIV acquisition among African Americans. Given limited literature and development of interventions for HIV-negative but high-risk heterosexual AA couples, there is a need for SAVA risk-reduction development tailored to this population. Phase 1 consisted of qualitative interviews with 16 couples who met study criteria to gather input and information to adapt an 8-session couple-based SAVA syndemic informed risk reduction intervention for HIV-negative, AA heterosexual couples who reported intimate partner violence (IPV) and substance abuse. Phase 2 is the focus of this trial and will consist of delivery of the intervention to 20 couples who meet study inclusion criteria to test the adapted intervention. Given the disproportionate impact of HIV on AAs, this study addresses a key gap in literature by testing the first SAVA informed risk-reduction intervention for high-risk, HIV-negative, heterosexual AA couples.

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Key information

Age range

18 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Maryland School of Public Health, Department of Family Sciences

College Park, Maryland, 20742, United States

About this study

Synergistic interactions between substance use, violence, and HIV/AIDS (SAVA syndemic) are closely linked with HIV acquisition among African Americans (AAs). However, no interventions have been developed to address SAVA syndemic risk-reduction for HIV-negative but high-risk heterosexual AA couples. This application builds on a qualitative study that was conducted during phase 1 of a NIDA-funded project. In phase 1, the investigators finalized and tested our recruitment protocol and conducted qualitative interviews with 16 couples who met study criteria. This application focused on phase 2 of the funded study. As part of this study the investigators will test an adapted 8-session couple-based SAVA syndemic informed risk-reduction intervention for HIV-negative, AA heterosexual couples who report intimate partner violence (IPV), and substance use. For this purpose, the investigators deliver the intervention to 20 couples who meet study inclusion criteria to test the adapted intervention. The intervention will be delivered online (via zoom) to individual couples. These couples will be recruited through social media (Facebook, Instagram, and Twitter) and advertising through local community-based organizations. The investigators will also inform the couples who participated in phase 1 qualitative interviews about the opportunity to participate in phase 2. Those who express an interest in participating in phase 2 will have to complete screening again to make sure they are eligible for the present study. This research will be done as part of a grant proposal funded by NIDA. Given the disproportionate impact of HIV on AAs, this study addresses a key gap in literature by testing the first SAVA informed risk-reduction intervention for high-risk, HIV-negative, heterosexual AA couples.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Both participants must:

  • be between 18-49 years old
  • self-identify as African American/Black
  • identify each other as the main/steady heterosexual partner
  • have been together for at least 2 months
  • plan to be together for at least 3 months
  • have had unprotected anal/ vaginal sex with their partner in the last 3 months.

At least one participant must have engaged in:

  • IPV in the relationship in the last 6 months
  • substance use in the last 6 months.

Exclusion criteria

  • <18 or >49 years of age
  • not being African American/ Black
  • not having a steady partner of the opposite sex for at least 2 months
  • not sexually active in the last 3 months
  • currently pregnant or planning a pregnancy in the next 6 months
  • not English language proficient
  • showing evidence of significant cognitive impairment at screening; and (h) reporting severe physical or sexual violence by partner in the last 6 months (required medical attention) or being fearful of the partner.

Treatment and study plan

Risk-Reduction Sessions

Behavioral

The 8-session intervention protocol emphasizes cognitive-behavioral interventions for anger management, conflict resolution, reducing sexual risk behavior, substance use, and enhancement of couple functioning.

Primary outcomes

  1. Condom use

    Time frame: 2-months

    frequency of protected and unprotected vaginal and anal sex

  2. Attitudes toward Sexual Partner Concurrency

    Time frame: 2-months

    10-item self-report measure of attitudes toward sexual partner concurrency

  3. Intimate Partner Violence

    Time frame: 2-months

    38-items Conflict Tactics Scale measures victimization and perpetration of physical, psychological, and sexual violence

  4. Drug use

    Time frame: 2-months

    10-item Drug Abuse Screening Test (DAST-10) will be used to assess changes in drug use

Secondary outcomes

  1. Mental Health

    Time frame: 2-months

    PHQ-9 will be used to assess depressive symptoms

  2. Relationship Satisfaction

    Time frame: 2-months

    Couple Satisfaction Index (CSI-16) will be used to assess relationship satisfaction

Sponsors and collaborators

Lead sponsor

University of Maryland, College Park

Other

Registry information

Official study title

An Integrated Substance Use, Violence, and HIV/AIDS Syndemic Risk-reduction Intervention for African American Couples

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 23, 2021
Registry last updated
Nov 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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