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Completed

NCT Number: NCT01187979

Reducing HIV in Adolescents

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.

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

13 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Vulindlela Clinical Research Site

Durban, KwaZulu-Natal, South Africa

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cash incentives

Behavioral

Cash incentives paid to learners for reaching pre-determined milestones

Life skills curriculum

Behavioral

Standard department of education lifeskills curriculum

Primary outcomes

  1. HIV-incidence rates

    Time frame: annually, after every 12 months of follow up

    To evaluate the efficacy of a cash-incentivised prevention intervention in reducing HIV-incidence rates in high-school learners

Secondary outcomes

  1. Academic performance measured as an overall passing grade (50%)

    Time frame: 6 monthly

    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.

  2. voluntary uptake of HIV testing

    Time frame: annually, after every 12 months of follow up

    Learners must provide the receipt from the clinic that specifies that the learner was tested for HIV.

  3. Substance use patterns

    Time frame: annually, after every 12 months of follow up

    Urine specimens will be utilised for testing for the presence of recreational drugs.

  4. Pregnancy rates in female learners

    Time frame: annually, after every 12 months of follow up

    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.

  5. Contraceptive use patterns in female learners

    Time frame: annually, after every 12 months of follow up

    Annual behavioural questionnaires will monitor self-reported contraceptive use.

  6. Participation in extra-curricular activities

    Time frame: annually, after every 12 months of follow up

    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.

  7. HIV risk reduction behaviour

    Time frame: Annually, after every 12 months of follow up

    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

Sponsors and collaborators

Lead sponsor

Centre for the AIDS Programme of Research in South Africa

Network

Collaborators

  • Embassy of the Kingdom of the Netherlands (EKN)
  • KwaZulu-Natal Department of Education
  • MIET Africa

Registry information

Official study 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

Acronym: RHIVA

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Aug 25, 2010
Registry last updated
Jan 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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