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SAVA Syndemic Risk Reduction for African American Couples

29. november 2021 oppdatert 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.

Studieoversikt

Status

Fullført

Forhold

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

20

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Maryland
      • College Park, Maryland, Forente stater, 20742
        • University of Maryland School of Public Health, Department of Family Sciences

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 49 år (Voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Condom use
Tidsramme: 2-months
frequency of protected and unprotected vaginal and anal sex
2-months
Attitudes toward Sexual Partner Concurrency
Tidsramme: 2-months
10-item self-report measure of attitudes toward sexual partner concurrency
2-months
Intimate Partner Violence
Tidsramme: 2-months
38-items Conflict Tactics Scale measures victimization and perpetration of physical, psychological, and sexual violence
2-months
Drug use
Tidsramme: 2-months
10-item Drug Abuse Screening Test (DAST-10) will be used to assess changes in drug use
2-months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Mental Health
Tidsramme: 2-months
PHQ-9 will be used to assess depressive symptoms
2-months
Relationship Satisfaction
Tidsramme: 2-months
Couple Satisfaction Index (CSI-16) will be used to assess relationship satisfaction
2-months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Mona Mittal, PhD, University of Maryland, College Park

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. mars 2021

Primær fullføring (Faktiske)

31. juli 2021

Studiet fullført (Faktiske)

31. juli 2021

Datoer for studieregistrering

Først innsendt

16. februar 2021

Først innsendt som oppfylte QC-kriteriene

19. februar 2021

Først lagt ut (Faktiske)

23. februar 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

30. november 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. november 2021

Sist bekreftet

1. november 2021

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • 5R03DA044866-02 (U.S. NIH-stipend/kontrakt)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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