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ComBaCaL HIV Prevention TwiCs (CoPrev)

2026年9月11日 更新者：University Hospital, Basel, Switzerland

Community-based, Village Health Worker-led, eHealth-supported, Integrated HIV Prevention for People at Substantial Risk of HIV Acquisition in Rural Lesotho: Protocol for a Cluster-randomized Hybrid Type 1 effectiveness-implementation Trial Within the ComBaCaL Cohort Study

This cluster-randomized intervention is embedded in the ComBaCaL (Community-Based Chronic disease care Lesotho) cohort study (EKNZ ID AO_2022-00058, clinicaltrials.gov ID NCT05596773, Lesotho NH-REC ID 210-2022), a platform for the investigation of chronic diseases and their management in rural Lesotho that is maintained by local lay chronic care village health workers (CC-VHWs).

This study is to evaluate the effectiveness and safety of the CoPrev model in regard to biomedical HIV prevention utilization compared with an enhanced standard of care, in which VHWs assisted by a tablet-based CDS application, perform the same activities except for the prescription and/or delivery of PEP, oral PrEP, COC and self-injectable contraception. Additionally, this study aims to assess the outcomes and processes related to the implementation of such a model.

調査の概要

状態

引きこもった

条件

介入・治療

詳細な説明

Approximately 1.3 million new HIV infections were reported worldwide in 2024. Eastern and Southern Africa continue to bear the largest share of the HIV-related burden. To prevent lingering epidemics in these low-resource, high-prevalence regions, it is essential to intensify HIV prevention efforts, including the scale-up of effective biomedical HIV prevention, such as Pre-Exposure (PrEP) and Post- Exposure Prophylaxis (PEP). However, uptake, persistent use and adherence to biomedical HIV prevention remains low among individuals at substantial risk of HIV acquisition, especially in rural areas. Thus, there is an urgent need for scalable, integrated, cost-effective, and context-specific service delivery models that increase the utilization of biomedical HIV prevention among populations at increased risk in Southern Africa.

This cluster-randomized intervention is embedded in the ComBaCaL (Community-Based Chronic disease care Lesotho) cohort study (EKNZ ID AO_2022-00058, clinicaltrials.gov ID NCT05596773, Lesotho NH-REC ID 210-2022), a platform for the investigation of chronic diseases and their management in rural Lesotho that is maintained by local lay chronic care village health workers (CC-VHWs).

The ComBaCaL HIV Preven7on (CoPrev) model is a differen7ated, community-based preven7on model, that provides eligible individuals with an alterna7ve to facility-based HIV preven7on and contracep7on. It builds on the broader ComBaCaL model of care, which extends the role of VHWs beyond educa7on, counselling, screening, and referral, to include ac7ve management of preven7on and care services for selected condi7ons. This is enabled through a tablet-based CDS applica7on, allowing VHWs to independently prescribe and deliver selected medica7ons at community level.

Within the CoPrev model, VHWs, assisted by the CDS application, deliver an integrated HIV prevention package comprising HIV prevention education and counselling; HIV and HIV risk screening; condom provision; referral to health facilities, and the prescription and delivery of PEP (TDF/3TC/DTG) and oral PrEP (TDF/3TC) to those eligible. In addition, VHWs provide contraceptive services, including family planning education and counselling; pregnancy screening; referral to health facilities; and the delivery of refills of combined oral contraception (COC) and self-injectable contraception to those eligible.

研究の種類

介入

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

  • スイス
      • Basel、スイス、4051
        • University of Basel, Division of Clinical Epidemiology
  • レソト
      • Maseru、レソト
        • SolidarMed Lesotho

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

  • 子
  • 大人
  • 高齢者

健康ボランティアの受け入れ

はい

説明

Inclusion Criteria:

  • Participant of the ComBaCaL cohort study (signed informed consent available)
  • Weight ≥ 35 kg
  • Negative HIV screening test
  • No potential exposure to HIV more than 72 hours ago (PEP eligibility window period) and less than 4 weeks ago (window period HIV test)

  • At substantial risk of HIV acquisition as per behavioural risk factors in the Lesotho's national HIV prevention and treatment guidelines:

    • Report of serodiscordant partner who are not virally suppressed or have an unknown viral suppression status (either not on ART, initiated ART within the last 6 months, known virally unsuppressed or unknown virally suppression status but believed not to be taking treatment regularly)
    • Report of sexual partner with unknown HIV status
    • Report of unprotected sex with more than one partner in the last 6 months
    • Report of STI by lab-testing or self-report of STI syndromic management in the last 6 months
    • Report of exchanging money/goods for sex in the last 6 months (as recipient and vice versa)
    • Report of intravenous drug use with shared equipment in the last 6 months
    • Request for biomedical HIV prevention

Exclusion Criteria:

  • Known allergies to PEP/oral PrEP
  • Known glomerular filtration rate (GFR) < 60 ml/min or diagnosis of moderate/severe kidney disease or kidney failure

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：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
アクティブコンパレータ：Intervention villages
In the intervention villages, VHWs will follow the standard service protocol of the ComBaCaL cohort study, but in line with the CoPrev model, will also be able to additionally prescribe and deliver drugs for biomedical HIV prevention (PEP (TDF/3TC/DTG 300mg/300mg/50mg) or oral PrEP (TDF/3TC 300mg/300mg)) and offer refills for contraception (EE/LNG 30mcg/15mcg or 50mcg/15mcg) or self-injectable contraception (s.c. 104mg/0.65ml medroxypregosteronacetate). VHWs will provide monitoring for all dispensed drug regimens, thereby ensuring comprehensive and integrated sexual and reproductive health services within their communities.
他の：CoPrev model
  • prescribe and deliver drugs for biomedical HIV prevenTion (PEP (TDF/3TC/DTG 300mg/300mg/50mg) or oral PrEP (TDF/3TC 300mg/300mg))
  • offer refills for contraception (EE/LNG 30mcg/15mcg or 50mcg/15mcg) or self-injectable contraception (s.c. 104mg/0.65ml medroxypregosteronacetate
  • monitoring for all dispensed drug regimens
アクティブコンパレータ：Control villages
In the control villages, VHWs will follow the standard service protocol of the ComBaCaL cohort study. Using the tablet-based CDS application, they will be trained and supervised to educate participants on HIV prevention, screen for HIV offering oral HIV self-tests, assess HIV risk behaviour, provide risk reduction counselling and condoms, and refer participants eligible for biomedical HIV prevention to the nearest health facility. Furthermore, they will offer family planning education, pregnancy screening, and refer participants for contraception.
他の：Referral to the nearest responsible health facility
  • refer participants eligible for biomedical HIV prevention to the nearest health facility
  • offer family planning education, pregnancy screening, and refer participants for contraception.

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
Monthly biomedical HIV prevention coverage over 6 months after enrolment
時間枠：Single assessment visit scheduled approximately six months after enrolment (180 days)
Biomedical HIV prevention coverage is defined at the person- month level as a binary indicator of whether a participant was covered by a biomedical HIV prevention method (PEP (TDF/3TC/DTG), oral PrEP (TDF/3TC), or injectable PrEP) during a given 30-day month within the six-month observation period following enrolment in the ComBaCaL HIV prevention TwiCs .
Single assessment visit scheduled approximately six months after enrolment (180 days)

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。

スポンサー

University Hospital, Basel, Switzerland

協力者

SolidarMed
The World Diabetes Foundation
Swiss Agency for Development and Cooperation

捜査官

  • 主任研究者：Niklaus Labhardt、Division of Clinical Epidemiology, University Hospital Basel

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 (推定)

2026年6月1日

一次修了 (推定)

2027年6月1日

研究の完了 (推定)

2027年6月1日

試験登録日

最初に提出

2026年5月5日

QC基準を満たした最初の提出物

2026年5月5日

最初の投稿 (実際)

2026年5月12日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月16日

QC基準を満たした最後の更新が送信されました

2026年9月11日

最終確認日

2026年9月1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

  • ub26Labhardt2

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?

はい

IPD プランの説明

An anonymized key dataset necessary for reproducing the primary and key secondary endpoints will be made freely available in an appropriate repository, such as zenodo.org, alongside the publication of the study results. Besides removal of variables not required for key analysis, we will remove participant identifier, study site and exact date information. Requests for access to more detailed data may be made to the corresponding author by submitting a proposal, which will be reviewed by the trial consortium.

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米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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