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Pilot HIV Self-Testing And Self-collected STI Testing Strategy for Sex Worker Empowerment Study (PHASES)

2026年9月14日 更新者：University of North Carolina, Chapel Hill

Pilot HIV Self-Testing And Self-collected STI Testing Strategy for Sex Worker Empowerment Study (PHASES)

The goal of this clinical trial is to find out if sex work managers (also called "queen mothers") can help female sex workers (FSW) get tested for HIV and other sexually transmitted infections (STIs) by giving out and collecting test kits at the places where FSW meet and work, also known as venues. This study will also find out if this approach helps link FSW to HIV and STI treatment and prevention services. The main questions it aims to answer are:

  • Can this approach increase HIV diagnosis and connection to HIV treatment and prevention services?
  • Can this approach increase STI diagnosis and connection to STI treatment services?
  • Is this approach acceptable, appropriate, and feasible, and what are the costs associated with the approach?

Researchers will compare a venue-based, peer-supported strategy for HIV self-testing and self-collected STI testing among FSW to the current standard of care to see if the new approach helps to increase HIV and STI identification and linkage to HIV and STI treatment and prevention services.

FSW participants will:

  • Complete questionnaires when they join the study and again about three months later.
  • Complete HIV self-testing and self-collected STI testing when they join the study and again about three months later (at intervention sites), with the help of queen mothers.
  • Agree to have their medical records reviewed.

Queen mother participants will:

  • Complete questionnaires when they join the study and again about three months later.
  • Help FSW participant complete HIV self-testing and self-collected STI testing when they join the study and again three months later (at intervention sites).

Additionally, some FSW participants will complete a one-time interview so that the investigators can learn more about their experiences with and views on HIV and STI services. The investigators will also be holding focus group discussions with queen mothers, clinicians, and others involved in study activities to understand their experiences with providing services through the study strategy.

調査の概要

状態

まだ募集していません

条件

介入・治療

研究の種類

介入

入学 (推定)

232

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。

研究連絡先

研究場所

  • ザンビア
    • Lusaka Province
      • Lusaka、Lusaka Province、ザンビア、10101
        • Centre for Infectious Disease Research in Zambia (CIDRZ) Head Office
        • コンタクト：

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

  • 大人
  • 高齢者

健康ボランティアの受け入れ

はい

説明

FSW Inclusion Criteria:

  • Born biologically female
  • Identifies as a woman
  • Aged 18 years or older
  • Exchanged sex for money, goods, or services in the last 6 months
  • Lived and/or worked in Lusaka for at least the last 3 months
  • Planning to remain in Lusaka for at least the next 3 months
  • Willing and able to provide contact information, including a reachable telephone number
  • Willing and able to provide informed consent in Nyanja, Bemba, or English

FSW Exclusion Criteria:

  • Under the age of 18 years
  • Does not identify as a woman
  • Unable and/or unwilling to provide contact information
  • Unable and/or unwilling to provide informed consent

Queen Mother Eligibility Criteria:

  • Aged 18 years or older
  • Currently engaged as a sex work manager ("queen mother")
  • Lived and/or worked in Lusaka for at least the last 3 months
  • Planning to remain in Lusaka for at least the next 6 months
  • Willing and able to provide contact information, including a reachable telephone number
  • Willing and able to provide informed consent in Nyanja, Bemba, or English

Implementer Focus Group Discussion Eligibility Criteria:

  • Aged 18 years old or older
  • Working as a queen mother OR civil society organization/Ministry of Health/non-governmental organization clinician or peer navigator OR member of a civil society or implementing partner organization serving FSW
  • Willing and able to provide verbal informed consent in English, Nyanja, or Bemba

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
実験的：Intervention Arm
At intervention sites, the investigators will consecutively enroll 50 female sex workers (FSW) per site and follow them for 3 months, with questionnaire administration, HIV self-testing (HIVST), and self-collected STI testing performed at enrollment and 3 months post-enrollment. At enrollment, participants will complete a one-time questionnaire on sociodemographic data, sexual history, medical history, and strategy acceptability and appropriateness, as well as HIVST and self-collected STI testing, with the assistance of queen mothers. Participants diagnosed with HIV and/or STIs will be linked to World Health Organization (WHO)-recommended treatment at venues or nearby drop-in centers (DICs) or Ministry of Health facilities per participant preference, and those who are HIV-negative will be linked to HIV prevention services, also through venues/DICs/health facilities per participant preference. HIVST and self-collected STI testing and questionnaires repeated 3 months after enrollment.
他の：Venue-based, peer-enhanced strategy for integrated HIV self-testing (and self-collected STI testing
Sex work managers, known as "queen mothers", will act as peer champions and will store, distribute, and collect HIV self-tests and self-collected STI test kits at venues where sex is sold on-site. Participants diagnosed with HIV and/or STIs will be linked to World Health Organization (WHO)-recommended treatment at venues or nearby drop-in centers (DICs) or Ministry of Health (MOH) health facilities based on participant preference, and those who are HIV-negative will be linked to HIV prevention services, also through venues or DICs or health facilities based on participant preference.
介入なし：Standard-of-Care Arm
At standard-of-care (SOC) sites, the investigators will enroll 50 FSW at each site for completion of study questionnaires at enrolment and at 3-month follow up. These FSW will continue receiving routine syndromic STI management and HIV screening and treatment as recommended by Zambian guidelines.

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
Uptake of HIV/STI testing through the strategy
時間枠：From enrollment to study follow up at 3 months post-enrollment.
Completion of HIV self-testing and self-collected STI testing among those offered HIV self-testing and self-collected STI testing through the strategy.
From enrollment to study follow up at 3 months post-enrollment.
Uptake of HIV testing
時間枠：From enrollment to study follow up at 3 months post-enrollment.
Completion of HIV testing among those not known to be living with HIV at enrollment.
From enrollment to study follow up at 3 months post-enrollment.
Completion of confirmatory HIV testing
時間枠：From enrollment to study follow up at 3 months post-enrollment.
Completion of confirmatory HIV testing among those with positive HIV self tests.
From enrollment to study follow up at 3 months post-enrollment.
HIV diagnosis
時間枠：From enrollment to study follow up at 3 months post-enrollment.
New diagnosis of HIV among those not known to be living with HIV at enrollment.
From enrollment to study follow up at 3 months post-enrollment.
HIV treatment linkage
時間枠：From enrollment to study follow up at 3 months post-enrollment.
Registered in the Zambian national HIV program (of those with HIV).
From enrollment to study follow up at 3 months post-enrollment.
HIV prevention linkage
時間枠：From enrollment to study follow up at 3 months post-enrollment.
Registered in the national HIV program (of those not living with HIV).
From enrollment to study follow up at 3 months post-enrollment.
Uptake of self-collected STI testing
時間枠：From enrollment to study follow up at 3 months post-enrollment.
Completed self-collected STI testing (of those offered testing through the strategy).
From enrollment to study follow up at 3 months post-enrollment.
Uptake of self-collected syphilis testing
時間枠：From enrollment to study follow up at 3 months post-enrollment.
Completed self-collected syphilis testing (of those offered testing through the strategy).
From enrollment to study follow up at 3 months post-enrollment.
Uptake of self-collected gonorrhea/chlamydia testing
時間枠：From enrollment to study follow up at 3 months post-enrollment.
Completed self-collected gonorrhea/chlamydia testing (of those offered testing through the strategy).
From enrollment to study follow up at 3 months post-enrollment.
STI diagnosis
時間枠：From enrollment to study follow up at 3 months post-enrollment.
Diagnosed with one or more microbiologically confirmed STIs (of those participating at intervention sites).
From enrollment to study follow up at 3 months post-enrollment.
STI syndromic diagnosis
時間枠：From enrollment to study follow up at 3 months post-enrollment.
Diagnosed with one or more STI syndromes (of those participating at SOC sites)
From enrollment to study follow up at 3 months post-enrollment.
STI treatment linkage
時間枠：From enrollment to study follow up at 3 months post-enrollment.
Received STI treatment (of those diagnosed with STIs and/or STI syndromes).
From enrollment to study follow up at 3 months post-enrollment.
Strategy acceptability
時間枠：At enrollment and at study follow up 3 months post-enrollment.
Acceptability of the components of our venue-based, peer-enhanced integrated HIV self-testing and self-collected STI testing strategy among female sex workers and implementers, using the Acceptability of Intervention Measure.
At enrollment and at study follow up 3 months post-enrollment.
Strategy appropriateness
時間枠：At enrollment and at study follow up 3 months post-enrollment.
Appropriateness of the components of our venue-based, peer-enhanced integrated HIV self-testing and self-collected STI testing strategy among female sex workers and implementers using the Intervention Appropriateness Measure.
At enrollment and at study follow up 3 months post-enrollment.
Strategy feasibility
時間枠：At enrollment and at study follow up 3 months post-enrollment.
Feasibility of the components of our venue-based, peer-enhanced integrated HIV self-testing and self-collected STI testing strategy among implementers using the Feasibility of Intervention Measure.
At enrollment and at study follow up 3 months post-enrollment.
Strategy costs
時間枠：From enrollment to study follow up at 3 months post-enrollment.
Variable and fixed costs associated with the strategy and expressed per participant.
From enrollment to study follow up at 3 months post-enrollment.

その他の成果指標

結果測定
メジャーの説明
時間枠
HIV incidence
時間枠：Between enrollment and study follow up at 3 months post-enrollment.
New HIV diagnoses among those with negative HIVST at enrollment and no known history of HIV prior to enrollment at intervention sites.
Between enrollment and study follow up at 3 months post-enrollment.
HIV prevalence
時間枠：At enrollment.
Known history of HIV or positive HIVST and confirmatory test at enrollment, among those participating at intervention sites.
At enrollment.
Syphilis prevalence
時間枠：At enrollment.
Diagnosed with syphilis at enrollment (of those participating at intervention sites).
At enrollment.
Syphilis incidence
時間枠：Between enrollment and study follow up at 3 months post-enrollment.
Diagnosed with syphilis at/before the 3-month study follow up visit (among those with negative syphilis testing at enrollment or those who were diagnosed with syphilis at enrollment and completed syphilis treatment at intervention sites).
Between enrollment and study follow up at 3 months post-enrollment.
Gonorrhea prevalence
時間枠：At enrollment.
Diagnosed with gonorrhea at enrollment (of those participating at intervention sites).
At enrollment.
Gonorrhea incidence
時間枠：Between enrollment and study follow up at 3 months post-enrollment.
Diagnosed with gonorrhea at/before the 3-month study follow up visit (among those with negative gonorrhea testing at enrollment or who completed gonorrhea treatment at enrollment at intervention sites).
Between enrollment and study follow up at 3 months post-enrollment.
Chlamydia prevalence
時間枠：At enrollment.
Diagnosed with chlamydia at enrollment (of those participating at intervention sites).
At enrollment.
Chlamydia incidence
時間枠：Between enrollment and study follow up at 3 months post-enrollment.
Diagnosed with chlamydia at/before the 3-month study follow up visit (among those with negative chlamydia testing at enrollment or who completed chlamydia treatment at enrollment at intervention sites).
Between enrollment and study follow up at 3 months post-enrollment.

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 of North Carolina, Chapel Hill

協力者

Fogarty International Center of the National Institute of Health

捜査官

  • 主任研究者：Stephanie F Sweitzer, MSPH, MD、University of North Carolina

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

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10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9月14日

QC基準を満たした最初の提出物

2026年9月14日

最初の投稿 (実際)

2026年9月18日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月18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14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

  • 26-1772
  • D43TW009340 (米国 NIH グラント/契約)

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?

いいえ

IPD プランの説明

Given the concern that sharing identifiable data could violate participant privacy around potentially stigmatizing information, this data will not be shared outside of the study team.

医薬品およびデバイス情報、研究文書

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

米国で製造され、米国から輸出された製品。

はい

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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