A Phase 2/3 interventional study of HIV/STD Risk-Reduction and Health Promotion in HIV Infections and Sexually Transmitted Disease, sponsored by University of Pennsylvania. Completed. Per ClinicalTrials.gov, last updated 2015-09-25.
Sponsored by University of Pennsylvania · Phase 2/3, Interventional, and Prevention
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
424 studies on the registry are indexed under Sexually Transmitted Diseases; 71 are open to participants now.
This study's enrollment of 1,057 is above the median of 470 across 346 interventional studies indexed under Sexually Transmitted Diseases.
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Of its 154 completed or terminated interventional studies of FDA-regulated products, 104 (68%) have results posted.
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Exclusion Criteria:
The HIV/STD Risk-Reduction Intervention arm focuses on reducing the risk of STDs, including HIV.
Behavioral: HIV/STD Risk-Reduction
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.
Behavioral: Health Promotion
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.
Also known as: Let Us Protect Our Future
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.
Protection use in sexual intercourse
Time frame: Measured at Month 12
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
Biologically confirmed STDs
Positive test for chlamydial infection, gonorrhea, and trichomoniasis
Time frame: Measured at Month 42
No study locations are listed for this record.
This study is completed, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.
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