Clinical trial NCT00559403: Effect of HIV/STD Risk Reduction Program on South African Adolescents
Official title: South African Adolescent Health Promotion Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: HIV Infections
Sexually Transmitted Disease
Keywords: Human immunodeficiency virus
South Africa
Intervention Studies
Sexual Behavior
Adolescents
STD
HIV Seronegativity
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2007-11-16
Enrollment: 1057
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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, 12, 42, and 54 months post-treatment. STDs will be assessed 42 and 54 months post-treatment

Eligibility 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

Primary outcomes:
measure: Protection use in sexual intercourse
timeFrame: Measured at Month 12
Secondary outcomes:
measure: Sexual intercourse considerations: number of sexual partners, sexual debut, anal intercourse, consistency of condom use
timeFrame: Measured at Month 12
measure: Theoretical mediators of abstinence (e.g., self-efficacy to avoid having sexual intercourse)
timeFrame: Measured at Month 12
measure: Theoretical mediators of condom use (e.g., self-efficacy to use condoms)
timeFrame: Measured at Month 12
measure: HIV/STD risk-reduction knowledge
timeFrame: Measured at Month 12
measure: Condom-use knowledge
timeFrame: Measured at Month 12
measure: Biologically confirmed STDs
timeFrame: Measured at Month 42
Other outcomes:
Locations:
Study officials:
affiliation: University of Pennsylvania
name: John B. Jemmott III, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.