Effect of HIV/STD Risk Reduction Program on South African Adolescents
South African Adolescent Health Promotion Project
調査の概要
詳細な説明
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
研究の種類
入学 (実際)
段階
- フェーズ2
- フェーズ 3
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：HIV/STD Sessions
The HIV/STD Risk-Reduction Intervention arm focuses on reducing the risk of STDs, including HIV.
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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.
他の名前：
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アクティブコンパレータ：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.
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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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
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Protection use in sexual intercourse
時間枠：Measured at Month 12
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Measured at Month 12
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Sexual intercourse considerations: number of sexual partners, sexual debut, anal intercourse, consistency of condom use
時間枠：Measured at Month 12
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Measured at Month 12
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Theoretical mediators of abstinence (e.g., self-efficacy to avoid having sexual intercourse)
時間枠：Measured at Month 12
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Measured at Month 12
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Theoretical mediators of condom use (e.g., self-efficacy to use condoms)
時間枠：Measured at Month 12
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Measured at Month 12
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HIV/STD risk-reduction knowledge
時間枠：Measured at Month 12
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Measured at Month 12
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Condom-use knowledge
時間枠：Measured at Month 12
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Measured at Month 12
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Biologically confirmed STDs
時間枠：Measured at Month 42
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Positive test for chlamydial infection, gonorrhea, and trichomoniasis
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Measured at Month 42
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協力者と研究者
捜査官
- 主任研究者：John B. Jemmott III, PhD、University of Pennsylvania
出版物と役立つリンク
一般刊行物
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
HIV感染症の臨床試験
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University of Alabama at BirminghamMobile County Health Deparment; Alabama Department of Public Health募集HIV | HIV検査 | HIV とケアの関係 | HIV治療アメリカ
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French National Agency for Research on AIDS and...Elizabeth Glaser Pediatric AIDS Foundation完了パートナーの HIV 検査 | カップルの HIV カウンセリング | カップルのコミュニケーション | HIV の発生率カメルーン, ドミニカ共和国, グルジア, インド
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University of Minnesota引きこもったHIV感染症 | HIV/エイズ | HIV | AIDS | エイズ・HIV問題 | エイズと感染症アメリカ
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Africa Health Research InstituteLondon School of Hygiene and Tropical Medicine; University College, London; University of Southampton と他の協力者募集
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ANRS, Emerging Infectious DiseasesHopital Universitaire Robert-Debre; Institut de Recherche pour le Developpement; Centre Pasteur... と他の協力者わからないHIV | HIVに感染していない子供たち | HIVにさらされた子供たちカメルーン
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Erasmus Medical Centerまだ募集していません
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University of Maryland, Baltimore引きこもった
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Hospital Clinic of Barcelona完了
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Helios SaludViiV Healthcareわからない
HIV/STD Risk-Reductionの臨床試験
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University of PennsylvaniaNational Institute of Mental Health (NIMH)完了
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University of PennsylvaniaNational Institute of Mental Health (NIMH); University of California, Los Angeles; Columbia University と他の協力者完了
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The University of Texas Health Science Center,...Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)完了
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Pacific Institute for Research and EvaluationNational Institute of Mental Health (NIMH)完了
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Virginia Commonwealth UniversityNational Institute on Minority Health and Health Disparities (NIMHD)完了
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Mississippi State UniversityNational Institute on Drug Abuse (NIDA)完了
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Centers for Disease Control and PreventionColorado Department of Public Health and Environment; San Francisco Department of Public Health と他の協力者完了性感染症 | HIV
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Washington University School of MedicineNational Institute on Drug Abuse (NIDA)完了性感染症 | HIV | 薬物乱用