Reducing HIV in Adolescents

HIV Infections Clinical Trial

— RHIVA  

Official title:

A Proof of Concept Cluster Randomised Controlled Trial to Evaluate the Impact of a Cash Incentivised Prevention Intervention to Reduce HIV Infection in High School Learners in Rural KwaZulu-Natal, South Africa

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01187979
• Other study ID #: CAPRISA 007
• Status: Completed
• Phase: Phase 2
• First received: August 12, 2010
• Last updated: January 18, 2017
• Start date: September 2010
• Est. completion date: August 2014

Study information

• Verified date: January 2017
• Source: Centre for the AIDS Programme of Research in South Africa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the impact of a cash-incentivised prevention intervention on reducing HIV incidence rates in high-school learners in rural KwaZulu-Natal.

Description:

The impact of the cash incentivised intervention will be assessed using a matched pair, cluster randomised controlled trial design. The 14 selected high schools in the Vulindlela School Circuit will be matched in pairs. The matched pairs of schools will be the unit of randomisation. Baseline measurements, using a standardised tool (structured questionnaire and biological specimens) will be undertaken simultaneously in each matched pair and will include all eligibly enrolled and consenting learners in the respective schools. On completion of baseline measurements in each matched pair of schools, the randomisation code for the pair will be revealed and the intervention will be implemented in the intervention school. All schools will receive the same prevention intervention but only the intervention school will receive the cash incentives. Follow-up measurements will be undertaken approximately 12 and 24 months after implementation of the intervention using a similar standardised assessment tool to that used at baseline. At baseline and during follow-up assessments in intervention and control schools, linked HIV and substance use testing will be undertaken in all learners and pregnancy testing in female learners. Other secondary endpoints will be assessed using a structured questionnaire.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3217
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years and older

Eligibility

Inclusion Criteria:

Learners must meet all of the following criteria at enrolment in order to be eligible for inclusion in the study:

• Male or female learner in Grade 9 or 10 in one of the 14 selected schools

• Willing and able to provide informed consent and/or assent to participate in the study

• Willing to provide locator data for home visits if necessary

• Not planning to move to another school or relocate in the next 36 months

• Willing to be finger-printed to verify identity for study procedure purposes

• Willing to participate in this study

• Willing to complete all study procedures

Exclusion Criteria:

• Refusal by the learner and/or parent or legal guardian to participate in the study.

• Unable to provide necessary informed consents

• Cognitively challenged learners

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Infection

Intervention

Behavioral:
• Cash incentives
Cash incentives paid to learners for reaching pre-determined milestones
• Life skills curriculum
Standard department of education lifeskills curriculum

Locations

Country	Name	City	State
South Africa	Vulindlela Clinical Research Site	Durban	KwaZulu-Natal

Sponsors (4)

Lead Sponsor	Collaborator
Centre for the AIDS Programme of Research in South Africa	Embassy of the Kingdom of the Netherlands (EKN), KwaZulu-Natal Department of Education, MIET Africa

Country where clinical trial is conducted

South Africa, 

References & Publications (3)

Fernald LC, Hou X, Gertler PJ. Oportunidades program participation and body mass index, blood pressure, and self-reported health in Mexican adults. Prev Chronic Dis. 2008 Jul;5(3):A81. — View Citation

Hargreaves JR, Glynn JR. Educational attainment and HIV-1 infection in developing countries: a systematic review. Trop Med Int Health. 2002 Jun;7(6):489-98. Review. — View Citation

Pettifor AE, Rees HV, Kleinschmidt I, Steffenson AE, MacPhail C, Hlongwa-Madikizela L, Vermaak K, Padian NS. Young people's sexual health in South Africa: HIV prevalence and sexual behaviors from a nationally representative household survey. AIDS. 2005 Sep 23;19(14):1525-34. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HIV-incidence rates	To evaluate the efficacy of a cash-incentivised prevention intervention in reducing HIV-incidence rates in high-school learners	annually, after every 12 months of follow up
Secondary	Academic performance measured as an overall passing grade (50%)	To support learners improving academic performance, attend school, complete schooling and improve their self-esteem, learners will be incentivised to pass their June and November examinations, with a minimum of a 50% average. Educators from the selected schools will design, administer and mark the June and November examination papers.	6 monthly
Secondary	voluntary uptake of HIV testing	Learners must provide the receipt from the clinic that specifies that the learner was tested for HIV.	annually, after every 12 months of follow up
Secondary	Substance use patterns	Urine specimens will be utilised for testing for the presence of recreational drugs.	annually, after every 12 months of follow up
Secondary	Pregnancy rates in female learners	A dipstick pregnancy test will be performed on the urine sample of all female learners at baseline and at the two annual follow-up visits.	annually, after every 12 months of follow up
Secondary	Contraceptive use patterns in female learners	Annual behavioural questionnaires will monitor self-reported contraceptive use.	annually, after every 12 months of follow up
Secondary	Participation in extra-curricular activities	Attendance and participation in a life skills/sustainable livelihoods programme will be assessed. Self-reported participation in extra-curricular activities will be assessed in annual behavioural questionnaires.	annually, after every 12 months of follow up
Secondary	HIV risk reduction behaviour	The following will be assessed through a self-reported questionnaire: condom use; primary and/or secondary sexual abstinence rates; sexually transmitted disease rates intergenerational sexual coupling (age of sexual partner(s)) age of sexual debut; frequency of HIV testing; number of concurrent sex partners; frequency of partner change; medical male circumcision rates; anal sex rates	Annually, after every 12 months of follow up

External Links

•   CAPRISA website