Clinical trial NCT04205721: Impact Evaluation of a School-Based Sexuality and HIV Prevention Education Activity in South Africa
Official title: Impact Evaluation of a School-Based Sexuality and HIV Prevention Education Activity in South Africa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HSV-2 Infection
HIV Infections
Pregnancy Related
Keywords: HIV prevention
School-based programming
Pregnancy prevention
South Africa
Genital herpes
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: University of Pretoria
name: SADC Research Centre
First posted: 2019-12-19
Enrollment: 23061
Sex: ALL
Minimum age (years): 11
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized cluster design whereby schools were assigned to intervention or control schools before the trial began.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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?

Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

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

Primary outcomes:
measure: Change in HSV-2 experience (Incidence of HSV-2)
timeFrame: Baseline and 24 month follow-up
measure: Change in pregnancy experience (Pregnancy incidence)
timeFrame: Baseline, 12 month and 24 month follow-up
measure: Change in HSV-2 or pregnancy experience (combined outcome)
timeFrame: Baseline and 24 month follow-up
Secondary outcomes:
measure: Knowledge of HIV risk score
timeFrame: Collected at baseline, 12 month and 24 month follow-up
measure: Gender norm attitudes (based on the Gender Equitable Men Scale)
timeFrame: Collected at baseline, 12 month and 24 month follow-up
measure: Percentage of learners who were tested for HIV in the last 12 months
timeFrame: Collected at baseline, 12 month and 24 month follow-up
measure: HIV prevalence
timeFrame: 24 month follow-up period only
measure: Self-reported sexual experience - percentage
timeFrame: Collected at baseline, 12 month and 24 month follow-up
measure: Self-reported number of sexual partners, among sexually experienced - percentage
timeFrame: Collected at baseline, 12 month and 24 month follow-up
measure: Self-reported condom use, among sexually experienced - percentage
timeFrame: Collected at baseline, 12 month and 24 month follow-up
Other outcomes:
Locations:
city: Cape Town
country: South Africa
facility: Darryn Durno
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Ilene Speizer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Speizer IS, Mandal M, Xiong K, Hattori A, Makina-Zimalirana N, Kumalo F, Taylor S, Ndlovu MS, Madibane M, Beke A. Methodology and Baseline Results From the Evaluation of a Sexuality Education Activity in Mpumalanga and KwaZulu-Natal, South Africa. AIDS Educ Prev. 2018 Apr;30(2):152-168. doi: 10.1521/aeap.2018.30.2.152.
citation: Speizer IS, Xiong K, Mandal M, Makina-Zimalirana N, Hattori A, Durno D. HIV-Related Knowledge, Attitudes, and Behaviors among Grade 10 Girls and Boys in Mpumalanga and KwaZulu-Natal: Cross-Sectional Results. Open AIDS J. 2020;14:75-83. doi: 10.2174/1874613602014010075. Epub 2020 Sep 18.
citation: Speizer IS, Mandal M, Xiong K, Makina N, Hattori A, Durno D. Impact evaluation of scripted lesson plans for HIV-related content in a life orientation curriculum: results from two provinces in South Africa. BMC Public Health. 2020 Oct 14;20(1):1542. doi: 10.1186/s12889-020-09640-2.