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临床试验/NCT04205721
NCT04205721已完成不适用

Impact Evaluation of a School-Based Sexuality and HIV Prevention Education Activity in South Africa

University of North Carolina, Chapel Hill1 个研究点 分布在 1 个国家目标入组 23,061 人开始时间: 2016年8月8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
23,061
试验地点
1
主要终点
Change in HSV-2 or pregnancy experience (combined outcome)

研究概览

简要总结

The purpose of this study is to evaluate the impact of the new South African Department of Basic Education (DBE) sexuality and HIV education program that uses scripted lesson plans and supporting activities and will be implemented by Education Development Center (EDC). The primary outcomes are the incidence of HSV-2 or pregnancy among a cohort of learners in grade 8 and followed for two years in two provinces of South Africa.

详细描述

This evaluation focuses on the HIV and sexual and reproductive health (SRH) content of the Government of South Africa life orientation (LO) Curriculum. In 2010, the Department of Basic Education (DBE) undertook assessments of their LO program and learned that while young people who participated in the program had improved knowledge and attitudes, the program was not being implemented uniformly, such that the results were inconsistent across schools and learners. To address these concerns, DBE, with support from the United States Agency for International Development (USAID) and the United States President's Emergency Plan for AIDS Relief (PEPFAR), developed scripted lesson plans (SLP) to strengthen the SRH content and standardize implementation across schools; these SLP were paired with supporting activities to address fidelity in the curriculum's delivery. The SLP were integrated in the LO program, with most of the lessons offered in the first half of the school year. The lessons were developed for grades 4-6, 7-9, and 10-12. This evaluation focuses on the curricula for grades 7-9 and 10-12. There are eight lessons for grade 7, eight for grade 8, 11 for grade 9, and 10 for grade 10. Notably, there were delays in getting DBE approvals for release of the grade-10 curriculum.

A key component of the program is that all LO teachers are trained on the new materials prior to implementation. Since 2015, USAID/PEPFAR has provided technical support to DBE for program roll out in priority provinces and districts that have the highest HIV incidence and prevalence. Technical support includes educator training on the new SLP and considerations of approaches for scale-up beyond the initial districts. Support for the first phase of implementation and testing was led by Education Development Center, with funding from USAID.

The goal of the proposed impact evaluation is to assess the impact of the LO program on students over time. The primary evaluation question is: What is the effect of the scripted lesson plans and supporting activities on the incidence of HSV-2 or pregnancy after two years among a cohort of girls enrolled in grade 8 at intervention schools compared to a cohort of girls in grade 8 at control schools providing the current life skills program (i.e., the standard of practice)?

The secondary evaluation questions include:

  • What is the effect of the scripted lesson plans and supporting activities on knowledge, attitudes, school retention, and self-reported risk behavior, HIV testing, and completed referrals for health services at the end of 8th, 9th, and 10th grade among a cohort of girls first interviewed in grade 8 and among a cross-section girls and boys interviewed in grade 8, grade 9 and grade 10?
  • If there is a reduction in the primary outcome, does the intervention work by increasing school retention, or is the effect independent of school retention?

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 (Participant)

盲法说明

Participants are either in intervention or control schools (intervention schools received the new curriculum); participants did not know about this prior assignment.

入排标准

年龄范围
11 Years 至 25 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • For the main cohort sample - females in grade 8 were enrolled in 2016 and followed for two years. All participating girls had to
  • receive parental consent,
  • provide assent, and
  • give contact information for study linking.
  • For the cross-sectional samples, female and male learners in grade 8 in 2016; in grade 9 in 2017 and in grade 10 in 2018 were eligible to participate assuming
  • they had parental consent and
  • assented to participate.

排除标准

  • Must understand one of the five languages that the survey was administered in.

结局指标

主要结局

Change in HSV-2 or pregnancy experience (combined outcome)

时间窗: Baseline and 24 month follow-up

Percentage of girls in the longitudinal cohort who experience either incident HSV-2 infection or a pregnancy since baseline. This is measuring a change her her status.

Change in HSV-2 experience (Incidence of HSV-2)

时间窗: Baseline and 24 month follow-up

Numerator: number of girls in the longitudinal cohort that test positive for genital herpes (HSV-2); Denominator: all cohort girls who did not have HSV-2 at baseline HSV-2 is measured using biomarkers. Dried blood spots were collected at baseline and again and endline. The baseline dried blood spots were stored in freezers until after analysis of the endline dried blood spots. Those who tested positive for genital herpes at endline were tested at baseline to determine if it was a new (incident) infection or if the girl already had genital herpes at baseline. The incidence measure is a change from her earlier status.

Change in pregnancy experience (Pregnancy incidence)

时间窗: Baseline, 12 month and 24 month follow-up

The percentage of girls in the longitudinal cohort who were never pregnant at baseline and who experience a pregnancy (self-reported) by endline. This is measuring a change in her experience with a pregnancy (incidence).

次要结局

  • Percentage of learners who were tested for HIV in the last 12 months(Collected at baseline, 12 month and 24 month follow-up)
  • HIV prevalence(24 month follow-up period only)
  • Self-reported number of sexual partners, among sexually experienced - percentage(Collected at baseline, 12 month and 24 month follow-up)
  • Self-reported condom use, among sexually experienced - percentage(Collected at baseline, 12 month and 24 month follow-up)
  • Knowledge of HIV risk score(Collected at baseline, 12 month and 24 month follow-up)
  • Gender norm attitudes (based on the Gender Equitable Men Scale)(Collected at baseline, 12 month and 24 month follow-up)
  • Self-reported sexual experience - percentage(Collected at baseline, 12 month and 24 month follow-up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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