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Effect of HIV/STD Risk Reduction Program on South African Adolescents

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
John Jemmott, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00559403
First received: November 14, 2007
Last updated: September 23, 2015
Last verified: September 2015

November 14, 2007
September 23, 2015
October 2004
June 2010   (final data collection date for primary outcome measure)
Protection use in sexual intercourse [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ]
Protection use in sexual intercourse [ Time Frame: Measured at Month 12 ]
Complete list of historical versions of study NCT00559403 on ClinicalTrials.gov Archive Site
  • Sexual intercourse considerations: number of sexual partners, sexual debut, anal intercourse, consistency of condom use [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ]
  • Theoretical mediators of abstinence (e.g., self-efficacy to avoid having sexual intercourse) [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ]
  • Theoretical mediators of condom use (e.g., self-efficacy to use condoms) [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ]
  • HIV/STD risk-reduction knowledge [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ]
  • Condom-use knowledge [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ]
  • Biologically confirmed STDs [ Time Frame: Measured at Month 42 ] [ Designated as safety issue: No ]
    Positive test for chlamydial infection, gonorrhea, and trichomoniasis
  • Sexual intercourse considerations: number of sexual partners, sexual debut, anal intercourse, consistency of condom use [ Time Frame: Measured at Month 12 ]
  • Theoretical mediators of abstinence (e.g., self-efficacy to avoid having sexual intercourse) [ Time Frame: Measured at Month 12 ]
  • Theoretical mediators of condom use (e.g., self-efficacy to use condoms) [ Time Frame: Measured at Month 12 ]
  • HIV/STD risk-reduction knowledge [ Time Frame: Measured at Month 12 ]
  • Condom-use knowledge [ Time Frame: Measured at Month 12 ]
Not Provided
Not Provided
 
Effect of HIV/STD Risk Reduction Program on South African Adolescents
South African Adolescent Health Promotion Project
This study will evaluate the effect of an HIV/STD risk-reduction program on the sexual behavior of South African adolescents.

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

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
  • HIV Infections
  • Sexually Transmitted Disease
  • Behavioral: HIV/STD Risk-Reduction
    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.
    Other Name: Let Us Protect Our Future
  • Behavioral: Health Promotion
    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.
  • Experimental: HIV/STD Sessions
    The HIV/STD Risk-Reduction Intervention arm focuses on reducing the risk of STDs, including HIV.
    Intervention: Behavioral: HIV/STD Risk-Reduction
  • Active Comparator: Health Promotion Control Sessions
    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: Behavioral: Health Promotion

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1057
June 2010
June 2010   (final data collection date for primary outcome measure)

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
Both
Child, Adult, Senior
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00559403
R01MH065867, R01MH065867, DAHBR AZ-A
No
Not Provided
Not Provided
John Jemmott, University of Pennsylvania
University of Pennsylvania
National Institute of Mental Health (NIMH)
Principal Investigator: John B. Jemmott III, PhD University of Pennsylvania
University of Pennsylvania
September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP