- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04766697
SAVA Syndemic Risk Reduction for African American Couples
29 november 2021 uppdaterad av: University of Maryland, College Park
An Integrated Substance Use, Violence, and HIV/AIDS Syndemic Risk-reduction Intervention 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.
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
20
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Maryland
-
College Park, Maryland, Förenta staterna, 20742
- University of Maryland School of Public Health, Department of Family Sciences
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 49 år (Vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Receive Intervention
All 20 couples will receive the 8-session adapted intervention.
|
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.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Condom use
Tidsram: 2-months
|
frequency of protected and unprotected vaginal and anal sex
|
2-months
|
|
Attitudes toward Sexual Partner Concurrency
Tidsram: 2-months
|
10-item self-report measure of attitudes toward sexual partner concurrency
|
2-months
|
|
Intimate Partner Violence
Tidsram: 2-months
|
38-items Conflict Tactics Scale measures victimization and perpetration of physical, psychological, and sexual violence
|
2-months
|
|
Drug use
Tidsram: 2-months
|
10-item Drug Abuse Screening Test (DAST-10) will be used to assess changes in drug use
|
2-months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Mental Health
Tidsram: 2-months
|
PHQ-9 will be used to assess depressive symptoms
|
2-months
|
|
Relationship Satisfaction
Tidsram: 2-months
|
Couple Satisfaction Index (CSI-16) will be used to assess relationship satisfaction
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2-months
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Mona Mittal, PhD, University of Maryland, College Park
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 mars 2021
Primärt slutförande (Faktisk)
31 juli 2021
Avslutad studie (Faktisk)
31 juli 2021
Studieregistreringsdatum
Först inskickad
16 februari 2021
Först inskickad som uppfyllde QC-kriterierna
19 februari 2021
Första postat (Faktisk)
23 februari 2021
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
30 november 2021
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
29 november 2021
Senast verifierad
1 november 2021
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 5R03DA044866-02 (U.S.S. NIH-anslag/kontrakt)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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