Evaluating a Structural and Behavioral HIV Risk Reduction Program for Black Men (MENCount)
2018年12月4日 更新者: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.
調査の概要
研究の種類
介入
入学 (実際)
455
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
District of Columbia
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Washington、District of Columbia、アメリカ、20052
- George Washington University
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年~40年 (大人)
健康ボランティアの受け入れ
はい
受講資格のある性別
男
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:防止
- 割り当て:非ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的: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.
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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.
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アクティブコンパレータ: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.
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general health intervention for men, not inclusive of HIV or relationship health
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Condom Use/Unprotected Sex - Redefined as Sexual Risk - 12 Month Follow-up
時間枠:12 month follow-up
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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.
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12 month follow-up
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Condom Use/Unprotected Sex - Redefined as Sexual Risk - 6 Month Follow-up
時間枠:6 month follow-up
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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.
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6 month follow-up
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Non-viral STI - 12 Month Follow-up
時間枠:12 month follow-up
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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
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12 month follow-up
|
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Non-viral STI - 6 Month Follow-up
時間枠:6 month follow-up
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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
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6 month follow-up
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者:Anita Raj, PhD、UCSD
- 主任研究者:Lisa Bowleg, PhD、George Washington University
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2013年3月1日
一次修了 (実際)
2017年4月1日
研究の完了 (実際)
2018年5月1日
試験登録日
最初に提出
2012年9月22日
QC基準を満たした最初の提出物
2012年9月25日
最初の投稿 (見積もり)
2012年9月26日
学習記録の更新
投稿された最後の更新 (実際)
2018年12月28日
QC基準を満たした最後の更新が送信されました
2018年12月4日
最終確認日
2018年12月1日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- R01MH096657 (米国 NIH グラント/契約)
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