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Social Capital and Engagement in Care Among Young Black Men Who Have Sex With Men Living With HIV

23 augustus 2021 bijgewerkt door: Sophia Hussen, Emory University
The study is a randomized controlled trial to evaluate the social capital intervention versus a general health promotion intervention (Health for Life; H4L) among groups of Young black men who have sex with men (YBMSM) and to measure the social capital and engagement in care with the HIV-positive YBMSM at 3 and 9 months.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Young black men who have sex with men (YBMSM) have high rates of HIV infection, and are also at risk for falling out of clinical care. Social capital, which refers to the resources in a person's social network, has been shown to be beneficial for people living with HIV in other places. The study wants to understand and build upon social capital in the YBMSM population in Atlanta, with the goal of ultimately improving HIV-related outcomes for these youth.

To achieve this study is conducted in 3 phases. In Phase I, study will conduct interviews with YBMSM and community leaders to get advice about developing a social capital intervention that will improve social capital. Phase II is a randomized controlled trial of groups of YBMSM implementing the social capital intervention versus groups of YBMSM receiving a general health promotion intervention (Health for Life; H4L). This is followed by Phase III which is mainly to measure the social capital and engagement in care with the HIV-positive YBMSM at 3 and 9 month timepoints.

The study plan to enroll 180 total participants (120 in the randomized controlled trial and 60 in preliminary interviews) over the four year study period.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

77

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Georgia
      • Atlanta, Georgia, Verenigde Staten, 30322
        • Emory University 1518 Clifton Rd

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 29 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Mannelijk

Beschrijving

Inclusion Criteria:

  • Age <= 29 years and >= 18 years
  • Self-identify as Black/African-American (inclusive of multiracial identities)
  • Male sex at birth
  • Endorse history of sex with men ever (inclusive of gay and bisexual men)
  • HIV-positive (self-reported by participant and confirmed by medical record)
  • Able and willing to provide written consent and participate in surveys, interviews, and/or group intervention

Exclusion Criteria:

  • Age < 18 years or >= 30 years
  • Unwilling or unable to provide written informed consent
  • Enrollment in one phase of the study is an exclusion criteria for enrollment in other phases

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: social capital intervention
This group will receive intervention developed from Phase 1 study and based on photovoice project
Gedragsmatig: social capital intervention
The social capital intervention will focus on developing skills and group-work that culminate in participant-derived photovoice projects. Each group of YBMSM will be encouraged to complete a 30 day photovoice challenge. The 30 day challenge is based on a prior community action project done as a part of our Centers for AIDS Research (CFAR)-funded research, which was a Photovoice project conducted by Dr. Hussen. Photovoice is a participatory action research methodology in which groups of individuals from a population of interest are given cameras to document events, people and places of significance in their lives.
Actieve vergelijker: group-based health promotion intervention
The intervention will be a modified version of "Health for Life" or H4L, which was used as a control arm intervention in a recently completed protocol of the Adolescent Trials Network which was co-chaired by Dr. Harper (University of Michigan)
Gedragsmatig: group-based health promotion intervention
The control arm will participate in a health education intervention that will be delivered in a group, but without a specific goal of creating group cohesion or social capital. The intervention will be a modified version of "Health for Life" or H4L, which was used as a control arm intervention in a recently completed protocol of the Adolescent Trials Network which was co-chaired by Dr. Harper (University of Michigan).

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Modified Social Capital Scale (MSCS) between the social capital intervention group and group-based health promotion intervention
Tijdsspanne: Baseline, 4 months after beginning intervention, 10 months after beginning intervention
Modified Social Capital Scale (MSCS) is an In-Depth Interview Guide that asks questions about social capital and engagement in care. The scale is recently modified, pilot tested, and validated Chen's Social Capital Scale. The instrument contained 10 composite items based on 42 items for assessing personally owned social capital, including bonding and bridging capitals. The questionnaire is a open ended questionnaire with probe questions. The scale contains subscales for bonding and bridging capital, and it also contains items that specify sources (including family, friends, and lesbian, gay, bisexual, and transgender (LGBT) organizations) and types of support (e.g. emotional support, instrumental support and informational support). The data will be transcribed verbatim by a professional business transcription service. Thematic analysis using a combination of inductive and deductive coding will be conducted to analyze the score.
Baseline, 4 months after beginning intervention, 10 months after beginning intervention

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in viral load suppression measured as copies/ml at baseline, post-intervention 3 months and 9 months between the social capital intervention group and group-based health promotion intervention
Tijdsspanne: Baseline, 4 months and 10 months
Viral load values will be extracted from the participants' electronic medical records (EMR). Viral load refers to the number of viral particles found in each millilitre of blood. Viral load tests measure the amount of HIV's genetic material in a blood sample. The results of a viral load test are described as the number of copies of HIV RNA in a millilitre of blood. The viral load test should consistently detect and measure virus levels down to 50 copies/mL, have a high specificity and provide reproducible results. The technologies used are advanced and very sensitive for measuring the amount of HIV genetic material present in the blood.
Baseline, 4 months and 10 months
Change in number of receiving two or more cluster of differentiation 4 (CD4) tests at baseline, post-intervention 3 months and 9 months between the social capital intervention group and group-based health promotion intervention
Tijdsspanne: Up to 10 months
Retention in Care will be measured by determining receiving two or more cluster of differentiation 4 (CD4) tests. This information will be gathered from subject's electronic medical record
Up to 10 months
Number of HIV visits at baseline, post-intervention 3 months and 9 months between the social capital intervention group and group-based health promotion intervention
Tijdsspanne: Up to 10 months
Retention in Care will be measured by determining participation in continuous care, that is, at least two or more routine HIV visits at least three months apart. This information will be gathered from subject's electronic medical record
Up to 10 months
Change in subjects self report to question at baseline, post-intervention 3 months and 9 months between the social capital intervention group and group-based health promotion intervention
Tijdsspanne: Baseline and 10 months
Adherence to antiretroviral medications will be measured using a composite of single item self-report question and pharmacy refill records that will be conducted and evaluated at baseline and at 9 months.
Baseline and 10 months
Number of viral load tests at post-intervention 3 months and 9 months between the social capital intervention group and group-based health promotion intervention
Tijdsspanne: Up to 10 months
Retention in Care will be measured by determining receiving two or more viral load tests. This information will be gathered from subject's electronic medical record.
Up to 10 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Emory University

Medewerkers

Centers for Disease Control and Prevention

Onderzoekers

  • Hoofdonderzoeker: Sophia Hussen, M.D., M.P.H., Emory University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

26 juli 2018

Primaire voltooiing (Werkelijk)

9 april 2021

Studie voltooiing (Werkelijk)

9 april 2021

Studieregistratiedata

Eerst ingediend

7 september 2018

Eerst ingediend dat voldeed aan de QC-criteria

7 september 2018

Eerst geplaatst (Werkelijk)

11 september 2018

Updates van studierecords

Laatste update geplaatst (Werkelijk)

27 augustus 2021

Laatste update ingediend die voldeed aan QC-criteria

23 augustus 2021

Laatst geverifieerd

1 augustus 2021

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • IRB00088255

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

Nee

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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