Pilot HIV Self-Testing And Self-collected STI Testing Strategy for Sex Worker Empowerment Study (PHASES)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 232
- 试验地点
- 1
- 主要终点
- Uptake of HIV/STI testing through the strategy
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Venue-based, peer-enhanced strategy for integrated HIV self-testing (and self-collected STI testing (Other)
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.
结局指标
主要结局
Uptake of HIV/STI testing through the strategy
时间窗: 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.
Uptake of HIV testing
时间窗: 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.
Completion of confirmatory HIV testing
时间窗: From enrollment to study follow up at 3 months post-enrollment.
Completion of confirmatory HIV testing among those with positive HIV self tests.
HIV diagnosis
时间窗: 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.
HIV treatment linkage
时间窗: From enrollment to study follow up at 3 months post-enrollment.
Registered in the Zambian national HIV program (of those with HIV).
HIV prevention linkage
时间窗: From enrollment to study follow up at 3 months post-enrollment.
Registered in the national HIV program (of those not living with HIV).
Uptake of self-collected STI testing
时间窗: From enrollment to study follow up at 3 months post-enrollment.
Completed self-collected STI testing (of those offered testing through the strategy).
Uptake of self-collected syphilis testing
时间窗: From enrollment to study follow up at 3 months post-enrollment.
Completed self-collected syphilis testing (of those offered testing through the strategy).
Uptake of self-collected gonorrhea/chlamydia testing
时间窗: From enrollment to study follow up at 3 months post-enrollment.
Completed self-collected gonorrhea/chlamydia testing (of those offered testing through the strategy).
STI diagnosis
时间窗: 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).
STI syndromic diagnosis
时间窗: From enrollment to study follow up at 3 months post-enrollment.
Diagnosed with one or more STI syndromes (of those participating at SOC sites)
STI treatment linkage
时间窗: From enrollment to study follow up at 3 months post-enrollment.
Received STI treatment (of those diagnosed with STIs and/or STI syndromes).
Strategy acceptability
时间窗: 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.
Strategy appropriateness
时间窗: 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.
Strategy feasibility
时间窗: 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.
Strategy costs
时间窗: From enrollment to study follow up at 3 months post-enrollment.
Variable and fixed costs associated with the strategy and expressed per participant.
次要结局
未报告次要终点