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

23. september 2015 opdateret af: John Jemmott, University of Pennsylvania

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

1057

Fase

  • Fase 2
  • Fase 3

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: HIV/STD Sessions
The HIV/STD Risk-Reduction Intervention arm focuses on reducing the risk of STDs, including HIV.
Adfærdsmæssigt: 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.
Andre navne:
  • Let Us Protect Our Future
Aktiv komparator: 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.
Adfærdsmæssigt: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Protection use in sexual intercourse
Tidsramme: Measured at Month 12
Measured at Month 12

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Sexual intercourse considerations: number of sexual partners, sexual debut, anal intercourse, consistency of condom use
Tidsramme: Measured at Month 12
Measured at Month 12
Theoretical mediators of abstinence (e.g., self-efficacy to avoid having sexual intercourse)
Tidsramme: Measured at Month 12
Measured at Month 12
Theoretical mediators of condom use (e.g., self-efficacy to use condoms)
Tidsramme: Measured at Month 12
Measured at Month 12
HIV/STD risk-reduction knowledge
Tidsramme: Measured at Month 12
Measured at Month 12
Condom-use knowledge
Tidsramme: Measured at Month 12
Measured at Month 12
Biologically confirmed STDs
Tidsramme: Measured at Month 42
Positive test for chlamydial infection, gonorrhea, and trichomoniasis
Measured at Month 42

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Pennsylvania

Samarbejdspartnere

National Institute of Mental Health (NIMH)

Efterforskere

  • Ledende efterforsker: John B. Jemmott III, PhD, University of Pennsylvania

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 2004

Primær færdiggørelse (Faktiske)

1. juni 2010

Studieafslutning (Faktiske)

1. juni 2010

Datoer for studieregistrering

Først indsendt

14. november 2007

Først indsendt, der opfyldte QC-kriterier

15. november 2007

Først opslået (Skøn)

16. november 2007

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

25. september 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. september 2015

Sidst verificeret

1. september 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • R01MH065867 (U.S. NIH-bevilling/kontrakt)
  • DAHBR AZ-A (Anden identifikator: National Institute of Mental Health)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med HIV-infektioner

Kliniske forsøg med HIV/STD Risk-Reduction

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Gabon

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner