'HI-4-TU' Study: Health Improvement for Teen Ugandans Study
Enhanced HIV/Sexually Transmitted Infections and Pregnancy Prevention Study to Improve Adolescent Reproductive Health Services in Uganda
調査の概要
詳細な説明
The overall goal of this research to test the acceptability and effectiveness of two enhanced adolescent friendly reproductive health prevention interventions versus current routine care. In each intervention group, 152 adolescent mothers will be randomized to either the enhanced group peer support education and counseling intervention or to the enhanced one-to-one (individual) peer support education and counseling group with a young, model, peer educator trained to deliver Reproductive Health Education and counseling messages, beginning during pregnancy (≥ 28 weeks) and followed up to 9 months postpartum or study end at or after 6 months (whichever comes first). The control group will consist of 215 adolescent mothers randomized to routine care as provided at Mulago hospital (or the designated health facility) where midwives deliver group sessions during antenatal and postpartum care visits as well as standard PMTCT services including routine opt-out HIV C&T and availability of partner C&T. Syphilis testing should also be routinely provided and treatment provided for infected pregnant mothers and their partners as per local standard of care.
The 3 groups will be enrolled with study visits at 3, 6 and 9 months post partum however the intervention groups (Arms 2 and 3) will have additional visits at 36 weeks Antepartum, delivery, 6 and 10 weeks postpartum, Quantitative baseline data will be collected on routine demographic characteristics, reproductive history, pregnancy intentions and sexual risk/perceptions and HIV/Sexually Transmitted Infection status.
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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Wakiso DIstrict
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Kampala、Wakiso DIstrict、ウガンダ
- MUJHU Care Ltd
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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:
- Pregnant at ≥28 weeks of gestation
- Agreeing to provide written informed consent to be screened for and take part in the study
- Agreeing to provide adequate locator information with residence within 30 km
- Agreeing to a home visit
- Agreeing to come for follow up visits and to receive study follow up phone calls
Exclusion Criteria:
- Serious illness or social conditions that would prevent adherence to study requirements
- High risk pregnancy or fetal death in utero (with the exception of risk defined only by maternal age)
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:支持療法
- 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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介入なし:Routine Care
Group education/counseling from Antenatal clinic midwives, routine PMTCT, HIV C&T and family planning C&T services on request.
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実験的:Routine Care plus group support
Routine Care plus enhanced group support
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Routine Care plus enhanced group support, and peer education beginning every 4 weeks post enrollment to delivery and at 6 and 10 weeks, 3, 6 and 9 months post delivery.
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実験的:Routine Care plus individual support
Routine Care plus enhanced individual support
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Routine Care plus individual peer education and support beginning every 4 weeks post enrollment to delivery and at 6 and 10 weeks, 3, 6 and 9 months post delivery.
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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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Composite measure of consistent condom-use and use of an effective family planning method method
時間枠:A comparison of this binary outcome will be conducted at one year.
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A log-binomial regression model will be used to obtain the prevalence rate ratios.
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A comparison of this binary outcome will be conducted at one year.
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Incidence of any Sexually Transmitted Infection
時間枠:at one year
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Kaplan-Meier survival analysis will be conducted to determine differences in the probability of sexually transmitted infection between study arms.
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at one year
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協力者と研究者
スポンサー
協力者
捜査官
- 主任研究者:Florence Mirembe, MMED, PhD、MU-JHU Care Ltd
研究記録日
主要日程の研究
研究開始 (実際)
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
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- IRB00061475
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
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