Assessing Strategies for Increasing Male Involvement in Malawi's Antenatal Program
In sub-Saharan Africa, engaging men in HIV prevention, care, and treatment has proven challenging. Along all steps of the HIV care-seeking cascade, men exhibit worse care-seeking behaviors than women. They are less likely to be tested for HIV, initiate combination antiretroviral therapy (cART), and be retained in cART care. Additionally, men rarely engage in the care of their female sex partners, even though couple care-seeking is associated with marked improvements in condom use within HIV-discordant couples. Option B+, Malawi's program for providing immediate, lifelong combination antiretroviral therapy (cART) to all HIV-infected pregnant women at the time of diagnosis, is an important entry-point for involving male partners in care.
This is a pilot randomized controlled trial (N=200 women) comparing two strategies of male partner involvement within the Option B+ program. In both arms (patient referral and contract referral) women will be encouraged to invite their male partners to accompany them to the clinic for couple HIV counseling and testing. In the contract referral arm, if the couple does not present within one week, the male partner will receive a home visit encouraging them to present to the clinic. We will compare the two arms for 1) uptake of couple HIV counseling and testing (cHCT), 2) uptake of cART for women, and 3) linkage to care for HIV-infected men. Results are expected to inform a larger trial and ultimately improve care-seeking in Malawi's HIV program.
Objective 1: Determine acceptability of male partner recruitment for cHTC within an Option B+ context. We will assess acceptability of eligible females to participate in this pilot RCT and reasons for non-participation.
Objective 2: Assess whether study arm (patient referral versus contract referral) is associated with cHTC uptake. We will conduct a pilot randomized controlled trial (RCT) of male partner recruitment. This study will contain two arms: patient referral and contract referral for uptake of cHTC (primary outcome).
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Central District
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Lilongwe、Central District、マラウイ
- Bwaila District Hospital Antenatal Unit
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
18 years old or 16-17 years old and married
- Pregnant
- Received a positive HIV-test within the last day
- Will be in Lilongwe for the next month
- Able and willing to give locator information for >1 male partner in the Bwaila District Hospital catchment area (either a mobile number, a physical address, or both)
Exclusion Criteria:
- Enrolled/enrolling in the PROMISE study
- Initially Presenting with a male sex partner
研究計画
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:ヘルスサービス研究
- 割り当て: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 |
|---|---|
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アクティブコンパレータ:Patient referral
Women are given an invitation to give to a male partner inviting them to come to the clinic for important pregnancy information
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A patient agrees to recruit their partner using the invitation.
他の名前:
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実験的:contract referral
Same as control.
However, if the male partner does not present, a community worker will trace the partner in the community.
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A patient agrees to recruit their partner using the invitation.
他の名前:
A female partner signs a contract saying it is permissible for a community worker to trace a male sex partner in the community.
他の名前:
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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 |
|---|---|---|
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Number of Women Who Came With Their Partners and Received Couple Counseling and Testing
時間枠:three months
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Based on whether the female partner brings her male partner to the antenatal clinic for couple HIV counseling and testing (as recorded on study case report forms) as the primary measure of uptake.
We will compare time to couple HIV counseling and testing between groups using the Kaplan Meier method and a log rank test.
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three months
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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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Female First Option B+ Follow-up Visit
時間枠:three months
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It will be assessed whether the female participants return for their first Option B+ visit (using the clinic's routine Option B+ records).
The number retained will be compared.
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three months
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Male Linkage to Care
時間枠:one month from male presentation to the clinic
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It will be assessed whether newly diagnosed HIV-infected male partners are linked to care within one month of learning their HIV positive result with their partner.
This will be assessed from abstraction of routine clinic records at Martin Preuss Center.
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one month from male presentation to the clinic
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協力者と研究者
捜査官
- 主任研究者:Nora E Rosenberg, PhD、University of North Carolina, Chapel Hill
- 主任研究者:Mina Hosseinipour, MD、University of North Carolina, Chapel Hill
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 13-3707
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