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

NCT ID: NCT04205721

Last Updated: 2019-12-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23061 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-08
• Study Completion Date: 2018-11-15

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?

Conditions

HSV-2 Infection; HIV Infections; Pregnancy Related

Keywords

HIV prevention; School-based programming; Pregnancy prevention; South Africa; Genital herpes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Scripted lesson plan life orientation curriculum

Participants in this arm were in schools where the life orientation teachers in grades 7-9 (in 2016 and 2017) and grade 10 in 2018 were trained to use the new life orientation curriculum that included scripted lesson plans for the sexual and reproductive health content of the program. There are eight lessons for grade 7, eight for grade 8, 11 for grade 9, and 10 for grade 10.

Group Type: EXPERIMENTAL

School-based sexuality and HIV prevention scripted lesson plans

Intervention Type: BEHAVIORAL

The revised life orientation content and implementation approach were designed to address gaps in prior implementation of the sexuality and HIV education content. By using scripted lesson plans and training teachers to use these, it was thought that students would get better information and lessons on the material important for HIV prevention.

Standard life orientation curriculum

Participants in this arm were in schools where the standard life orientation curriculum was used with no additional training and no use of the new materials.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

School-based sexuality and HIV prevention scripted lesson plans

The revised life orientation content and implementation approach were designed to address gaps in prior implementation of the sexuality and HIV education content. By using scripted lesson plans and training teachers to use these, it was thought that students would get better information and lessons on the material important for HIV prevention.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pretoria

OTHER

Sponsor Role: collaborator

SADC Research Centre

UNKNOWN

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ilene Speizer, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

Darryn Durno

Cape Town, , South Africa

Countries

South Africa

References

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.

Reference Type: BACKGROUND

PMID: 29688772 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33362883 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33054742 (View on PubMed)

Study Documents

Document Type: Individual Participant Data Set

View Document

Other Identifiers

15-3217

Identifier Type: -

Identifier Source: org_study_id