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Completed

NCT Number: NCT00559403

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

This study will evaluate the effect of an HIV/STD risk-reduction program on the sexual behavior of South African adolescents.

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Key information

Conditions

HIV Infections Acquired Immunodeficiency Syndrome Behavior Blood-Borne Infections Communicable Diseases Disease Attributes Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Retroviridae Infections Sexual Behavior Sexually Transmitted Disease Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HIV/STD Risk-Reduction

Behavioral

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 names: Let Us Protect Our Future

health promotion

Behavioral

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 outcomes

  1. Protection use in sexual intercourse

    Time frame: Measured at Month 12

Secondary outcomes

  1. Sexual intercourse considerations: number of sexual partners, sexual debut, anal intercourse, consistency of condom use

    Time frame: Measured at Month 12

  2. Theoretical mediators of abstinence (e.g., self-efficacy to avoid having sexual intercourse)

    Time frame: Measured at Month 12

  3. Theoretical mediators of condom use (e.g., self-efficacy to use condoms)

    Time frame: Measured at Month 12

  4. HIV/STD risk-reduction knowledge

    Time frame: Measured at Month 12

  5. Condom-use knowledge

    Time frame: Measured at Month 12

  6. Biologically confirmed STDs

    Time frame: Measured at Month 42

    Positive test for chlamydial infection, gonorrhea, and trichomoniasis

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

South African Adolescent Health Promotion Project

Important dates

Study start
2004
Primary completion
2010
Study completion
2010
First posted
Nov 16, 2007
Registry last updated
Sep 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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