Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201901837047199 Date of Approval: 15/01/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Revealing a safe sex option to reduce HIV risk: a cluster-randomized trial in Botswana.
Official scientific title Revealing a safe sex option to reduce HIV risk: a cluster-randomized trial in Botswana.
Brief summary describing the background and objectives of the trial 2.1 million new HIV infections occur every year, and disproportionately affect adolescent girls and young women. Abstinence-only risk avoidance approaches have had limited impact on reducing new infections. This cluster-randomized trial examines a risk reduction approach to curbing risky sex in school-going girls in Botswana conducted from August, 2014-December, 2015.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Prevention
Anticipated trial start date 29/08/2014
Actual trial start date 05/09/2014
Anticipated date of last follow up 01/12/2015
Actual Last follow-up date 09/12/2015
Anticipated target sample size (number of participants) 231
Actual target sample size (number of participants) 229
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group HIV Risk Information and Safe Sex Options 1-hour dose. Once. The intervention is a 1-hour class revealing the relative HIV risks of older versus younger partners. At baseline, over 90% of students guess this wrong: they think older partners are safest. Thus, at the outset, students do not realize dating same-age partners is a viable safer sex alternative. The intervention reveals this realistic and attractive safer sex strategy through five segments: ice-breakers to generate comfort talking about sex, a puzzle activity where youth guess in groups which age group of men is most likely to have HIV, a reveal of the true HIV graph disaggregated by age with statistics pulled from the Botswana AIDS Impact Survey (2013), a 14-minute video produced by UNICEF showcasing a young girl overcoming an older partner in a rural setting, and a short group discussion on the risks of intergenerational sex as well as actionable lessons learned to avoid risky older partners, including community support to draw on. 113
Control Group Government Standard of Care 12 sessions. Over the course of the term. The control group received the standard of care for youth in schools. This is typically a guidance & counseling teacher delivering the living life skills program, which covers comprehensive sexual education, and abstinence messaging. In practice, 80% of students have not heard of the life skills program. Instead, teachers often focus on abstinence-only messaging and general HIV knowledge. 116 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Primary and junior school students in grade 6, 9 or 10. Students below grade 6, in grade 7 or 11. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 10 Year(s) 19 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 24/06/2014 HRDC Ministry of Health
Ethics Committee Address
Street address City Postal code Country
Nelson Mandela Dr, Gaborone, Botswana Gaborone 00000 Botswana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pregnancy as measured by being missing from school due to pregnancy. 12 months follow-up.
Secondary Outcome Self-reported sexual behavior. 12 months follow-up.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ministry of Education Government enclave Gaborone, Botswana Gaborone Botswana
FUNDING SOURCES
Name of source Street address City Postal code Country
MAC AIDS 130 Prince St New York 10012 United States of America
JPAL University of Cape Town, Rondebosch Cape Town South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Young 1ove 6789 Seboko Gaborone Botswana Charities/Societies/Foundation
Primary Sponsor Botswana Baylor Childrens Clinical Center of Excellence 1836 Hospital Way Gaborone Botswana Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
JPAL University of Cape Town, Rondebosch Cape Town South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Gabriel Anabwani ganabwani@baylorbotswana.org.bw 2673190079 1836 Hospital Way
City Postal code Country Position/Affiliation
Gaborone Botswana Former Executive Director
Role Name Email Phone Street address
Scientific Enquiries Noam Angrist noam.angrist@bsg.ox.ac.uk 26777400830 2683 Seboko
City Postal code Country Position/Affiliation
Gaborone Botswana Executive Director
Role Name Email Phone Street address
Public Enquiries Noam Angrist nangrist@gmail.com 26777400830 2683 Seboko
City Postal code Country Position/Affiliation
Gaborone Botswana Executive Director
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
No
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information