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

NCT04205721 | Completed

• 1 other identifier: 15-3217
• Study Type: interventional
• Target: 23,061
• Locations: 1 country
• Sites: 1

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.

Conditions

HSV-2 Infection; HIV Infections; Pregnancy Related

Keywords

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

Outcome Measures

Primary Outcomes (3)

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

  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.

  Baseline and 24 month follow-up

• Change in pregnancy experience (Pregnancy incidence)

  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).

  Baseline, 12 month and 24 month follow-up

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

  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.

  Baseline and 24 month follow-up

Secondary Outcomes (7)

• 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

• 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 sexual experience - percentage

  Collected at baseline, 12 month and 24 month follow-up

Study Arms (2)

Scripted lesson plan life orientation curriculum

EXPERIMENTAL

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.

Behavioral: School-based sexuality and HIV prevention scripted lesson plans

Standard life orientation curriculum

NO INTERVENTION

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.

Interventions

School-based sexuality and HIV prevention scripted lesson plans 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.

Scripted lesson plan life orientation curriculum

Eligibility Criteria

• Age: 11 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• University of Pretoria: collaborator
• SADC Research Centre: collaborator

Study Sites (1)

Darryn Durno

Cape Town, South Africa

Location

Related Publications (3)

• 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.

  PMID: 29688772 BACKGROUND

• 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.

  PMID: 33362883 DERIVED

• 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.

  PMID: 33054742 DERIVED

MeSH Terms

Conditions

HIV Infections; Herpes Genitalis

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Herpes Simplex; Herpesviridae Infections; DNA Virus Infections; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Male; Male Urogenital Diseases

Study Officials

• Ilene Speizer, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are either in intervention or control schools (intervention schools received the new curriculum); participants did not know about this prior assignment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized cluster design whereby schools were assigned to intervention or control schools before the trial began.

Study Record Dates

• First Submitted: December 17, 2019
• First Posted: December 19, 2019
• Study Start: August 8, 2016
• Primary Completion: November 4, 2018
• Study Completion: November 15, 2018
• Last Updated: December 19, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Currently available
• Access Criteria: Request through data verse below.

Locations

ZA (1)