SAVA Clinical Trial
Official title:
An Integrated Substance Use, Violence, and HIV/AIDS Syndemic Risk-reduction Intervention for African American Couples
Verified date | November 2021 |
Source | University of Maryland, College Park |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | July 31, 2021 |
Est. primary completion date | July 31, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 49 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Maryland School of Public Health, Department of Family Sciences | College Park | Maryland |
Lead Sponsor | Collaborator |
---|---|
University of Maryland, College Park |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Condom use | frequency of protected and unprotected vaginal and anal sex | 2-months | |
Primary | Attitudes toward Sexual Partner Concurrency | 10-item self-report measure of attitudes toward sexual partner concurrency | 2-months | |
Primary | Intimate Partner Violence | 38-items Conflict Tactics Scale measures victimization and perpetration of physical, psychological, and sexual violence | 2-months | |
Primary | Drug use | 10-item Drug Abuse Screening Test (DAST-10) will be used to assess changes in drug use | 2-months | |
Secondary | Mental Health | PHQ-9 will be used to assess depressive symptoms | 2-months | |
Secondary | Relationship Satisfaction | Couple Satisfaction Index (CSI-16) will be used to assess relationship satisfaction | 2-months |