Trial record 12 of 21 for:    " October 17, 2007":" November 16, 2007"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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

This study has been completed.
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00559403
First received: November 14, 2007
Last updated: December 5, 2007
Last verified: November 2007
  Purpose

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


Condition Intervention Phase
HIV Infections
Sexually Transmitted Disease
Behavioral: HIV/STD Risk-Reduction
Behavioral: Health Promotion
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: South African Adolescent Health Promotion Project

Resource links provided by NLM:


Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • Protection use in sexual intercourse [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 1057
Study Start Date: October 2004
Study Completion Date: December 2006
Arms Assigned Interventions
Experimental: HIV/STD Sessions
The HIV/STD intervention arm focuses on reducing the risk of STDs, including HIV.
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
Active Comparator: Health Promotion Control Sessions
The health control arm focuses on 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
The health promotion treatment is structurally similar to the HIV/STD treatment: both include the same number of sessions and single-gender sessions led by Xhosa-speaking male and female co-facilitators. Treatment sessions focus on behaviors linked with risk of heart disease, diabetes, high blood pressure, certain cancers, alcohol and drug abuse, and motor vehicle accidents, 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.

Detailed Description:

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, and 12 post-treatment.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00559403

Sponsors and Collaborators
Investigators
Principal Investigator: John B. Jemmott III, PhD University of Pennsylvania
  More Information

No publications provided

Responsible Party: John B. Jemmott III, PhD, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00559403     History of Changes
Other Study ID Numbers: R01 MH065867, DAHBR AZ-A
Study First Received: November 14, 2007
Last Updated: December 5, 2007
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Human immunodeficiency virus
South Africa
Intervention Studies
Sexual Behavior
Adolescents
STD
HIV Seronegativity

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Infection
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on July 22, 2014