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临床试验/NCT05504954
NCT05504954已完成不适用

Multilevel Comprehensive HIV Prevention Package for South African Adolescent Girls and Young Women

University of Illinois at Chicago2 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2019年10月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
61
试验地点
2
主要终点
Number of AGYW Who Tested Positive for a Sexually Transmitted Infection (STI)

研究概览

简要总结

Programs which go beyond individual-level behavior change to reduce HIV and STI infections among adolescent girls and young women in sub-Saharan Africa are essential to meet global HIV targets. Informed, Motivated, Aware and Responsible Adolescents and Adults- South Africa (IMARA-SA) is an evidence-based HIV-prevention intervention for adolescent girls and young women (AGYW) and their female caregivers, which has been adapted for a South African audience. This pilot study will assess feasibility in preparation for a randomized controlled trial (RCT). Additionally, the pilot will examine the preliminary effectiveness of IMARA-SA in reducing sexually transmitted infections (STI) and increasing uptake of HIV testing and counseling (HTC) and pre-exposure prophylaxis (PrEP) at follow-up among AGYW. About 60 AGYW-FC dyads will be enrolled and randomized to IMARA-SA or a health-promotion control arm. Following randomization, the dyads will participate in an ~2-day group workshop (~10 hours), which includes joint and separate mother and daughter activities. AGYW and FC will complete baseline assessments and follow-up assessments approximately 6 months later. Assessments will include surveys, STIs testing (for chlamydia and gonorrhea), and uptake of HTC and a 1-month PrEP prescription. Additionally, the intervention's implementation (e.g., acceptability) will be explored.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
15 Years 至 19 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • AGYW will be excluded from the study if they do not have a FC to participate in the study.
  • AGYW and FC will be excluded from the study if they:
  • are unable to understand the consent/assent process and provide written informed consent;
  • are currently enrolled in another research study addressing HIV/STIs/PrEP;
  • participated in the IMARA-SA adaptation process. AGYW and FC must agree to participate as a dyad. AGYW refusal will supersede FC consent.

结局指标

主要结局

Number of AGYW Who Tested Positive for a Sexually Transmitted Infection (STI)

时间窗: 8-17 months post baseline

A positive test for at least one of two STIs: chlamydia and/or gonorrhea

Number of AGYW Completing HIV Testing and Counseling (HTC)

时间窗: 8-17 months post baseline

Completion of HIV Testing and Counseling (HTC)

Number of AGYW Who Elected to Take Pre-Exposure Prophylaxis (PrEP)

时间窗: 8-17 months post baseline

Uptake of Pre-Exposure Prophylaxis (PrEP) assessed as receipt of PrEP prescription from research team or other care provider after the baseline survey.

次要结局

  • AGYW Condom Use at Last Sex(6-10 months post baseline)
  • AGYW Consistency of Condom Use(6-10 months post baseline)
  • AGYW Substance Use During Sex in the Past 6 Months(6-10 months post baseline)
  • Number of Partners in the Past 6 Months(6-10 months post baseline)
  • AGYW's Report of Adherence to PrEP(6-10 months post baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Natasha Crooks

Assistant Professor, Human Development Nursing Science

University of Illinois at Chicago

研究点 (2)

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