Effect of HIV/STD Risk Reduction Program on South African Adolescents
Primary Purpose
HIV Infections, Sexually Transmitted Disease
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
HIV/STD Risk-Reduction
Health Promotion
Sponsored by
About this trial
This is an interventional prevention trial for HIV Infections focused on measuring Human immunodeficiency virus, South Africa, Intervention Studies, Sexual Behavior, Adolescents, STD, HIV Seronegativity
Eligibility Criteria
Inclusion Criteria:
- Schools, with Grade 6 learners, that served the general population of learners, not just those with learning disabilities
- Grade 6 learners at participating schools with signed parent/guardian consent forms
Exclusion Criteria:
- Schools exclusively serving children with learning disabilities
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
HIV/STD Sessions
Health Promotion Control Sessions
Arm Description
The HIV/STD Risk-Reduction Intervention arm focuses on reducing the risk of STDs, including HIV.
The Health Promotion Intervention arm focuses on physical activity, diet, and other behaviors linked to risk of heart disease, high blood pressure, stroke, diabetes, and certain cancers, which are all leading causes of morbidity and mortality among South Africans.
Outcomes
Primary Outcome Measures
Protection use in sexual intercourse
Secondary Outcome Measures
Sexual intercourse considerations: number of sexual partners, sexual debut, anal intercourse, consistency of condom use
Theoretical mediators of abstinence (e.g., self-efficacy to avoid having sexual intercourse)
Theoretical mediators of condom use (e.g., self-efficacy to use condoms)
HIV/STD risk-reduction knowledge
Condom-use knowledge
Biologically confirmed STDs
Positive test for chlamydial infection, gonorrhea, and trichomoniasis
Full Information
NCT ID
NCT00559403
First Posted
November 14, 2007
Last Updated
September 23, 2015
Sponsor
University of Pennsylvania
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00559403
Brief Title
Effect of HIV/STD Risk Reduction Program on South African Adolescents
Official Title
South African Adolescent Health Promotion Project
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pennsylvania
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will evaluate the effect of an HIV/STD risk-reduction program on the sexual behavior of South African adolescents.
Detailed Description
HIV is a virus that can lead to acquired immunodeficiency syndrome (AIDS), a disease that breaks down the immune system and allows for entry of life-threatening secondary infections. HIV is transmitted through the exchange of bodily fluids, primarily through sexual intercourse. South Africa has been one of the countries in which the AIDS pandemic has had an especially devastating effect. New cases of HIV infection in South Africa have been occurring at a high rate in people 15 to 24 years of age. There is no vaccine or cure for HIV yet, making disease prevention methods imperative. An important part of the prevention process is early education on HIV to reduce sexual-risk behavior and to promote safe sexual practices. This study will evaluate the effect of an HIV/STD risk-reduction program on the sexual behavior of South African adolescents.
In this single-blind study, participants will include sixth grade students from 18 South African schools that meet study criteria. The participants will be randomly divided into 2 structurally similar treatment groups. One group will take part in HIV/STD risk-reduction sessions, while the other group will take part in health promotion sessions. There will be 12 total sessions, each lasting 1 hour. The participants in the HIV/STD risk-reduction group will be taught to practice abstinence and condom use through interactive activities, comic workbooks, and take-home assignments. Through similar methods, the participants in the health promotion group will be taught about general health problems, such as heart disease, diabetes, alcohol and drug abuse, and certain cancers. Participants will also be taught healthful behaviors to help prevent these health problems. All participants will provide self-reports of sexual behavior and precautionary methods used in sexual intercourse immediately before the first and after the last treatment sessions. Follow-up evaluations will occur at Months 3, 6, 12, 42, and 54 months post-treatment. STDs will be assessed 42 and 54 months post-treatment
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Sexually Transmitted Disease
Keywords
Human immunodeficiency virus, South Africa, Intervention Studies, Sexual Behavior, Adolescents, STD, HIV Seronegativity
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1057 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HIV/STD Sessions
Arm Type
Experimental
Arm Description
The HIV/STD Risk-Reduction Intervention arm focuses on reducing the risk of STDs, including HIV.
Arm Title
Health Promotion Control Sessions
Arm Type
Active Comparator
Arm Description
The Health Promotion Intervention arm focuses on physical activity, diet, and other behaviors linked to risk of heart disease, high blood pressure, stroke, diabetes, and certain cancers, which are all leading causes of morbidity and mortality among South Africans.
Intervention Type
Behavioral
Intervention Name(s)
HIV/STD Risk-Reduction
Other Intervention Name(s)
Let Us Protect Our Future
Intervention Description
Let Us Protect Our Future consists of twelve 1-hour sessions to increase knowledge, motivation, and skills in practicing abstinence and condom use. It is highly structured, and Xhosa-speaking male and female co-facilitators implement the program using standardized manuals. Treatment sessions include mixed-gender and single-gender activities, games, brainstorming, and role-playing. Comic workbooks are used to address abstinence, condom use, and how risky behavior affects goals and dreams. The Xhosa culture is taken into account, including cultural transformations in urban township settings. Take-home assignments enlist parents' help to empower their children to reduce their STD risk and ensure that parents are aware of the nature of the treatment program.
Intervention Type
Behavioral
Intervention Name(s)
Health Promotion
Intervention Description
The health promotion treatment is structurally similar to the HIV/STD treatment: each has the same number of sessions and sessions led by Xhosa-speaking male and female co-facilitators. It focuses on behaviors linked with risk of heart disease, diabetes, high blood pressure, certain cancers, and alcohol and drug abuse, which are all leading causes of morbidity and mortality among South Africans. Participants are taught that healthful behaviors, including eating habits, physical activity, dental hygiene, and avoidance of cigarette smoking and substance use, can prevent these health problems. Comic workbook story lines are used to increase risk perception and awareness of health risks. Take-home assignments are used to foster communication with parents about healthful lifestyle.
Primary Outcome Measure Information:
Title
Protection use in sexual intercourse
Time Frame
Measured at Month 12
Secondary Outcome Measure Information:
Title
Sexual intercourse considerations: number of sexual partners, sexual debut, anal intercourse, consistency of condom use
Time Frame
Measured at Month 12
Title
Theoretical mediators of abstinence (e.g., self-efficacy to avoid having sexual intercourse)
Time Frame
Measured at Month 12
Title
Theoretical mediators of condom use (e.g., self-efficacy to use condoms)
Time Frame
Measured at Month 12
Title
HIV/STD risk-reduction knowledge
Time Frame
Measured at Month 12
Title
Condom-use knowledge
Time Frame
Measured at Month 12
Title
Biologically confirmed STDs
Description
Positive test for chlamydial infection, gonorrhea, and trichomoniasis
Time Frame
Measured at Month 42
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Schools, with Grade 6 learners, that served the general population of learners, not just those with learning disabilities
Grade 6 learners at participating schools with signed parent/guardian consent forms
Exclusion Criteria:
Schools exclusively serving children with learning disabilities
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John B. Jemmott III, PhD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
23962491
Citation
Jemmott LS, Jemmott JB 3rd, Ngwane Z, Icard L, O'Leary A, Gueits L, Brawner B. 'Let Us Protect Our Future' a culturally congruent evidenced-based HIV/STD risk-reduction intervention for young South African adolescents. Health Educ Res. 2014 Feb;29(1):166-81. doi: 10.1093/her/cyt072. Epub 2013 Aug 20.
Results Reference
background
PubMed Identifier
17505930
Citation
Jemmott JB 3rd, Heeren GA, Ngwane Z, Hewitt N, Jemmott LS, Shell R, O'leary A. Theory of planned behaviour predictors of intention to use condoms among Xhosa adolescents in South Africa. AIDS Care. 2007 May;19(5):677-84. doi: 10.1080/09540120601084308.
Results Reference
background
PubMed Identifier
25110841
Citation
Jemmott JB 3rd, Jemmott LS, O'Leary A, Ngwane Z, Lewis DA, Bellamy SL, Icard LD, Carty C, Heeren GA, Tyler JC, Makiwane MB, Teitelman A. HIV/STI risk-reduction intervention efficacy with South African adolescents over 54 months. Health Psychol. 2015 Jun;34(6):610-21. doi: 10.1037/hea0000140. Epub 2014 Aug 11.
Results Reference
result
PubMed Identifier
22618963
Citation
O'Leary A, Jemmott JB 3rd, Jemmott LS, Bellamy S, Ngwane Z, Icard L, Gueits L. Moderation and mediation of an effective HIV risk-reduction intervention for South African adolescents. Ann Behav Med. 2012 Oct;44(2):181-91. doi: 10.1007/s12160-012-9375-4.
Results Reference
result
PubMed Identifier
20921349
Citation
Jemmott JB 3rd, Jemmott LS, O'Leary A, Ngwane Z, Icard LD, Bellamy SL, Jones SF, Landis JR, Heeren GA, Tyler JC, Makiwane MB. School-based randomized controlled trial of an HIV/STD risk-reduction intervention for South African adolescents. Arch Pediatr Adolesc Med. 2010 Oct;164(10):923-9. doi: 10.1001/archpediatrics.2010.176.
Results Reference
result
PubMed Identifier
21318928
Citation
Jemmott JB 3rd, Jemmott LS, O'Leary A, Ngwane Z, Icard L, Bellamy S, Jones S, Landis JR, Heeren GA, Tyler JC, Makiwane MB. Cognitive-behavioural health-promotion intervention increases fruit and vegetable consumption and physical activity among South African adolescents: a cluster-randomised controlled trial. Psychol Health. 2011 Feb;26(2):167-85. doi: 10.1080/08870446.2011.531573.
Results Reference
result
PubMed Identifier
25668645
Citation
O'Leary A, Jemmott JB 3rd, Jemmott LS, Teitelman A, Heeren GA, Ngwane Z, Icard LD, Lewis DA. Associations between psychosocial factors and incidence of sexually transmitted disease among South African adolescents. Sex Transm Dis. 2015 Mar;42(3):135-9. doi: 10.1097/OLQ.0000000000000247.
Results Reference
result
PubMed Identifier
30646113
Citation
Jemmott JB 3rd, O'Leary A, Jemmott LS, Ngwane ZP, Teitelman AM, Makiwane MB, Bellamy SL. Effect of a Behavioral Intervention on Perpetrating and Experiencing Forced Sex Among South African Adolescents: A Secondary Analysis of a Cluster Randomized Trial. JAMA Netw Open. 2018 Aug 3;1(4):e181213. doi: 10.1001/jamanetworkopen.2018.1213. Erratum In: JAMA Netw Open. 2018 Oct 5;1(6):e184304.
Results Reference
derived
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Effect of HIV/STD Risk Reduction Program on South African Adolescents
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