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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
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

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

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    November 14, 2007
    Last Updated
    September 23, 2015
    Sponsor
    University of Pennsylvania
    Collaborators
    National Institute of Mental Health (NIMH)
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    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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