Social Capital and Engagement in Care Among Young Black Men Who Have Sex With Men Living With HIV
23. srpna 2021 aktualizováno: 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.
Přehled studie
Postavení
Dokončeno
Podmínky
Detailní popis
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.
Typ studie
Intervenční
Zápis (Aktuální)
77
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Georgia
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Atlanta, Georgia, Spojené státy, 30322
- Emory University 1518 Clifton Rd
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let až 29 let (Dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Mužský
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: social capital intervention
This group will receive intervention developed from Phase 1 study and based on photovoice project
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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.
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Aktivní komparátor: 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)
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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).
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in Modified Social Capital Scale (MSCS) between the social capital intervention group and group-based health promotion intervention
Časové okno: Baseline, 4 months after beginning intervention, 10 months after beginning intervention
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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.
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Baseline, 4 months after beginning intervention, 10 months after beginning intervention
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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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
Časové okno: Baseline, 4 months and 10 months
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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.
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Baseline, 4 months and 10 months
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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
Časové okno: Up to 10 months
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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
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Up to 10 months
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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
Časové okno: Up to 10 months
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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
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Up to 10 months
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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
Časové okno: Baseline and 10 months
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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.
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Baseline and 10 months
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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
Časové okno: Up to 10 months
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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.
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Up to 10 months
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Sophia Hussen, M.D., M.P.H., Emory University
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
26. července 2018
Primární dokončení (Aktuální)
9. dubna 2021
Dokončení studie (Aktuální)
9. dubna 2021
Termíny zápisu do studia
První předloženo
7. září 2018
První předloženo, které splnilo kritéria kontroly kvality
7. září 2018
První zveřejněno (Aktuální)
11. září 2018
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
27. srpna 2021
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
23. srpna 2021
Naposledy ověřeno
1. srpna 2021
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
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