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Evaluating a Structural and Behavioral HIV Risk Reduction Program for Black Men (MENCount)

4 december 2018 bijgewerkt door: Anita Raj, University of California, San Diego
The purpose of this study is to evaluate the effectiveness of the Making Employment Needs (MEN) Count intervention, an HIV intervention and prevention program for heterosexual Black men. The MEN Count model integrates HIV risk reduction and gender-equity counseling with housing and employment case management via multiple one-on-one sessions delivered by a peer case manager over 60-90 day period. MEN Count was developed and pilot tested using a Community-based participatory research (CBPR) approach via funding from a National Institutes of Health (NIH) R21, in Boston, Massachusetts. A more larger scale, two-armed quasi-experimental controlled trial design will be used to test MEN Count among Black men recruited/enrolled from an STD clinic and other community-recruitment methods in Washington, DC. Study participants (N=504) will be Black men reporting heterosexual risk for HIV [unprotected sex with a woman and 2+ female sex partners in the past 6 months] and either current unemployment or homeless in the past 6 months. To evaluate the effectiveness of MEN Count, a two-armed quasi-experimental design will be conducted in which participants will receive either MEN Count or an attention comparison program similar to MEN Count in structure. We will assess program impact on reduction in number of unprotected sex episodes and incident cases of STI (Chlamydia, gonorrhea, syphilis) via survey and STI testing, respectively, at baseline and 6 and 12 month follow-ups. Additionally, quality assurance and process evaluation efforts will be conducted to ensure high quality program adherence and delivery, as well as to support program replication should the model prove effective.

Studie Overzicht

Toestand

Voltooid

Conditie

Studietype

Ingrijpend

Inschrijving (Werkelijk)

455

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

    • District of Columbia
      • Washington, District of Columbia, Verenigde Staten, 20052
        • George Washington University

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 40 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Mannelijk

Beschrijving

Inclusion Criteria: Black men aged 18 and older, reporting heterosexual risk for HIV [unprotected sex with a woman and 2+ female sex partners in the past 6 months] and either current unemployment or homeless in the past 6 months.

Exclusion Criteria: planned to leave Washington D.C., Maryland, or Virginia in the next 6 months, were cognitively impaired (based on Folstein Mini-Mental Exam at recruitment or baseline testing), and/or had self-reported health status that prohibited them from participating in the program

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: Preventie
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: MEN Count
3 session HIV intervention including a) HIV risk reduction, inclusive of gender equity and healthy relationship counseling and b) case management support for stable employment and housing.
The MEN Count model integrates HIV risk reduction and gender-equity counseling with housing and employment case management via multiple one-on-one sessions delivered by a peer case manager over 60-90 day period.
Actieve vergelijker: Comparison
An attention comparison program similar to the MEN Count intervention in structure (3 one-on-one sessions delivered over 60-90 days) but focused on stress reduction and healthy lifestyle.
general health intervention for men, not inclusive of HIV or relationship health

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Condom Use/Unprotected Sex - Redefined as Sexual Risk - 12 Month Follow-up
Tijdsspanne: 12 month follow-up
Behavioral assessment of the ratio of protected to total number of sex episodes -- changed to sexual risk inclusive of inconsistent condom use in past 90 days + multiple sex partners + sex trade involvement. Very low sexual risk was defined as having one partner and consistent condom use. Low sexual risk was defined as having multiple partners and consistent condom use OR one partner and no/inconsistent condom use. Medium sexual risk was defined as having multiple partners, no/inconsistent condom use and not participating in transactional sex. High risk was defined as having multiple partners, no/inconsistent condom use, and participating in transactional sex. Participants reporting sex with men in the prior 90 days or who reported that they themselves or (one of) their partner(s) was HIV-positive were excluded from the sexual risk outcome given the known differential HIV risk profile for these subpopulations and small numbers of participants in each.
12 month follow-up
Condom Use/Unprotected Sex - Redefined as Sexual Risk - 6 Month Follow-up
Tijdsspanne: 6 month follow-up
Behavioral assessment of the ratio of protected to total number of sex episodes -- changed to sexual risk inclusive of inconsistent condom use in past 90 days + multiple sex partners + sex trade involvement. Very low sexual risk was defined as having one partner and consistent condom use. Low sexual risk was defined as having multiple partners and consistent condom use OR one partner and no/inconsistent condom use. Medium sexual risk was defined as having multiple partners, no/inconsistent condom use and not participating in transactional sex. High risk was defined as having multiple partners, no/inconsistent condom use, and participating in transactional sex. Participants reporting sex with men in the prior 90 days or who reported that they themselves or (one of) their partner(s) was HIV-positive were excluded from the sexual risk outcome given the known differential HIV risk profile for these subpopulations and small numbers of participants in each.
6 month follow-up

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Non-viral STI - 12 Month Follow-up
Tijdsspanne: 12 month follow-up
HIV and STI testing via blood and urine tests was conducted; outcome based on non-viral STI to allow for incidence assessment and change over time
12 month follow-up
Non-viral STI - 6 Month Follow-up
Tijdsspanne: 6 month follow-up
HIV and STI testing via blood and urine tests was conducted; outcome based on non-viral STI to allow for incidence assessment and change over time
6 month follow-up

Medewerkers en onderzoekers

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

Onderzoekers

  • Hoofdonderzoeker: Anita Raj, PhD, UCSD
  • Hoofdonderzoeker: Lisa Bowleg, PhD, George Washington 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)

1 maart 2013

Primaire voltooiing (Werkelijk)

1 april 2017

Studie voltooiing (Werkelijk)

1 mei 2018

Studieregistratiedata

Eerst ingediend

22 september 2012

Eerst ingediend dat voldeed aan de QC-criteria

25 september 2012

Eerst geplaatst (Schatting)

26 september 2012

Updates van studierecords

Laatste update geplaatst (Werkelijk)

28 december 2018

Laatste update ingediend die voldeed aan QC-criteria

4 december 2018

Laatst geverifieerd

1 december 2018

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • R01MH096657 (Subsidie/contract van de Amerikaanse NIH)

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