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

NCT00559403 | Completed Phase 2

• 2 other identifiers: R01MH065867DAHBR AZ-A
• Study Type: interventional
• Target: 1,057
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

HIV Infections; Sexually Transmitted Disease

Keywords

Human immunodeficiency virus; South Africa; Intervention Studies; Sexual Behavior; Adolescents; STD; HIV Seronegativity

Outcome Measures

Primary Outcomes (1)

• Protection use in sexual intercourse

  Measured at Month 12

Secondary Outcomes (6)

• Sexual intercourse considerations: number of sexual partners, sexual debut, anal intercourse, consistency of condom use

  Measured at Month 12

• Theoretical mediators of abstinence (e.g., self-efficacy to avoid having sexual intercourse)

  Measured at Month 12

• Theoretical mediators of condom use (e.g., self-efficacy to use condoms)

  Measured at Month 12

• HIV/STD risk-reduction knowledge

  Measured at Month 12

• Condom-use knowledge

  Measured at Month 12

Study Arms (2)

HIV/STD Sessions

EXPERIMENTAL

The HIV/STD Risk-Reduction Intervention arm focuses on reducing the risk of STDs, including HIV.

Behavioral: HIV/STD Risk-Reduction

Health Promotion Control Sessions

ACTIVE COMPARATOR

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

Interventions

HIV/STD Risk-Reduction BEHAVIORAL

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

HIV/STD Sessions

Health Promotion BEHAVIORAL

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.

Health Promotion Control Sessions

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Schools exclusively serving children with learning disabilities

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Institute of Mental Health (NIMH): collaborator

Related Publications (8)

• 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.

  PMID: 23962491 BACKGROUND

• 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.

  PMID: 17505930 BACKGROUND

• 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.

  PMID: 25110841 RESULT

• 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.

  PMID: 22618963 RESULT

• 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.

  PMID: 20921349 RESULT

• 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.

  PMID: 21318928 RESULT

• 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.

  PMID: 25668645 RESULT

• 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.

  PMID: 30646113 DERIVED

MeSH Terms

Conditions

HIV Infections; Sexually Transmitted Diseases; Acquired Immunodeficiency Syndrome; Sexual Behavior

Interventions

Health Promotion

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Slow Virus Diseases; Behavior

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• John B. Jemmott III, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Kenneth B. Clark Professor of Communication and Psychiatry

Study Record Dates

• First Submitted: November 14, 2007
• First Posted: November 16, 2007
• Study Start: October 1, 2004
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: September 25, 2015

Record last verified: 2015-09