HSV-2 InfectionNCT04205721
Impact Evaluation of a School-Based Sexuality and HIV Prevention Education Activity in South Africa
A study testing School-based sexuality and HIV prevention scripted lesson plans in people with HSV-2 Infection and HIV Infections, run by University of North Carolina, Chapel Hill at 1 site in South Africa.
Trial 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). Read more about this study
- Who is it for?
- Ages 11 to 25 years
- Conditions the study is for
- HSV-2 Infection, HIV Infections, Pregnancy Related
- What is being tested?
- School-based sexuality and HIV prevention scripted lesson plans
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23,061 participants
- Where
- 1 siteSouth Africa
- Study dates
- 8 Aug 2016to 15 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Must understand one of the five languages that the survey was administered in.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- School-based sexuality and HIV prevention scripted lesson plans
- Keywords
- HIV prevention, School-based programming, Pregnancy prevention, South Africa, Genital herpes
- Medical subject headings
- HIV Infections, Herpes Genitalis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
School-based sexuality and HIV prevention scripted lesson plansBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: Baseline and 24 month follow-up
Secondary outcomes (7)
Knowledge of HIV risk score
Eight items were measured at each survey round to determine young people's knowledge of how HIV spreads. Each question was posed as a "True," "False," or "Don't know" option. Correct responses were coded one and incorrect or don't know responses were coded zero. Correct responses were summed so that a higher knowledge score indicates greater knowledge about HIV risk.
Measured: Collected at baseline, 12 month and 24 month follow-up
Gender norm attitudes (based on the Gender Equitable Men Scale)
This was measured at each survey round using 17 items that were designed based on the Gender Equitable Men Scale, with additional items added. All questions were asked on a scale of "Agree a lot" to "Do not agree at all." These were coded as Agree a lot=1 to Do not agree at all =3. All were recoded so that higher values represent more equitable attitudes. We sum up the 17 items so that the summed scale equates to higher values being more equitable attitudes.
Measured: Collected at baseline, 12 month and 24 month follow-up
Percentage of learners who were tested for HIV in the last 12 months
This was measured at each survey round by asking participants to self report if they visited a facility for an HIV test in the last 12 months. This is used to examine participants experience with HIV testing and if there are changes over time across the study groups.
Measured: Collected at baseline, 12 month and 24 month follow-up
HIV prevalence
Using dried blood spots collected in the female cross-sectional sample at endline as well as the female cohort, the investigators are able to measure the prevalence of HIV at endline. This was an outcome that was added in the course of the study and was not part of the original protocol.
Measured: 24 month follow-up period only
Self-reported sexual experience - percentage
Measured by self-reported sexual initiation (age of sexual initiation)
Measured: Collected at baseline, 12 month and 24 month follow-up
Self-reported number of sexual partners, among sexually experienced - percentage
Measured by self-reported number of sexual partners in the last year. This will be categorized once the distribution is examined.
Measured: Collected at baseline, 12 month and 24 month follow-up
Self-reported condom use, among sexually experienced - percentage
Measured by percentage of learners who self-report that they used a condom at last sex.
Measured: Collected at baseline, 12 month and 24 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2019
- Study start8 Aug 2016
- Primary completion4 Nov 2018
- Study completion15 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HSV-2 InfectionStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized cluster design whereby schools were assigned to intervention or control schools before the trial began.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 23,061 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pretoria, SADC Research Centre
- Responsible party
- Sponsor
- Investigators
- Ilene Speizer, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04205721
- Sponsor's protocol ID
- 15-3217
- Status last verified
- Dec 2019
- First submitted
- 17 Dec 2019
- Last updated
- 19 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data are available on a publicly available server: https://dataverse.unc.edu/dataverse/cpc
Publications
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.
PubMed 29688772Speizer 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.
PubMed 33362883Speizer 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.
PubMed 33054742
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact Evaluation of a School-Based Sexuality and HIV Prevention Education Activity in South Africa
- ClinicalTrials.gov ID
- NCT04205721
- Acronym / sponsor ID
- 15-3217
- Conditions
- HSV-2 Infection, HIV Infections, Pregnancy Related
- Keywords
- HIV prevention, School-based programming, Pregnancy prevention, South Africa, Genital herpes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23,061 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- University of Pretoria, SADC Research Centre
- Study start
- 8 Aug 2016 (actual)
- Primary completion
- 4 Nov 2018 (actual)
- Study completion
- 15 Nov 2018 (actual)
- First posted
- 19 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized cluster design whereby schools were assigned to intervention or control schools before the trial began.
| Arm | Type | Receives |
|---|---|---|
| Scripted lesson plan life orientation curriculum | Experimental | Behavioral: School-based sexuality and HIV prevention scripted lesson plansParticipants 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. |
| 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. |
Who may qualify
- Ages
- 11 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- Must understand one of the five languages that the survey was administered in.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| School-based sexuality and HIV prevention scripted lesson plansThe 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. | Behavioural | Scripted lesson plan life orientation curriculum |
Primary outcome
Change in HSV-2 experience (Incidence of HSV-2)
Time frame: 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)
Time frame: 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).
Change in HSV-2 or pregnancy experience (combined outcome)
Time frame: 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.
7 secondary outcomes
Knowledge of HIV risk score
Time frame: Collected at baseline, 12 month and 24 month follow-up
Gender norm attitudes (based on the Gender Equitable Men Scale)
Time frame: Collected at baseline, 12 month and 24 month follow-up
Percentage of learners who were tested for HIV in the last 12 months
Time frame: Collected at baseline, 12 month and 24 month follow-up
HIV prevalence
Time frame: 24 month follow-up period only
Self-reported sexual experience - percentage
Time frame: Collected at baseline, 12 month and 24 month follow-up
Self-reported number of sexual partners, among sexually experienced - percentage
Time frame: Collected at baseline, 12 month and 24 month follow-up
Self-reported condom use, among sexually experienced - percentage
Time frame: Collected at baseline, 12 month and 24 month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2019.
- Background: PubMed 29688772Speizer 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.
- Derived from this study: PubMed 33362883Speizer 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.
- Derived from this study: PubMed 33054742Speizer 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.
- Individual participant dataSharing planned: Yes. De-identified data are available on a publicly available server: https://dataverse.unc.edu/dataverse/cpc
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ilene Speizer, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing School-based sexuality and HIV prevention scripted lesson plans in people with HSV-2 Infection and HIV Infections, run by University of North Carolina, Chapel Hill at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HSV-2 experience (Incidence of HSV-2) (time frame: Baseline and 24 month follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04205721, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2019.