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HIV InfectionsPhase 2RHIVANCT01187979

Reducing HIV in Adolescents

A Phase 2 study testing Cash incentives and Life skills curriculum in people with HIV Infections, run by Centre for the AIDS Programme of Research in South Africa at 1 site in South Africa.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 13 years and olderHealthy volunteers can take part
Conditions the study is for
HIV Infections
What is being tested?
Cash incentives and Life skills curriculum
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,217 participants
Where
1 siteSouth Africa
Study dates
Sep 2010to Aug 2014
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Refusal by the learner and/or parent or legal guardian to participate in the study.
  • Unable to provide necessary informed consents
  • Cognitively challenged learners

Trial locations and contacts

1 site in 1 country.

South Africa1 site

  • Vulindlela Clinical Research Site

    Durban, KwaZulu-Natal

Other trials in South Africa

About this study

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

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.

Read the detailed 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.

Conditions
HIV Infections
Being tested
Cash incentives, Life skills curriculum
Keywords
Cash incentive, HIV prevention, Adolescents, South Africa, HIV
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cash incentivesBehavioural

    Cash incentives paid to learners for reaching pre-determined milestones

  • Life skills curriculumBehavioural

    Standard department of education lifeskills curriculum

Study groups in NCT01187979
Study groupRoleWhat they receive
ControlActive comparatorAll eligibly enrolled learners in the intervention schools will receive a prevention program delivered by MIET Africa and the KwaZulu-Natal Department of Education. No cash incentives will be paid for meeting milestones
Receives: Behavioral: Life skills curriculum
Cash incentiveExperimentalAll eligibly enrolled learners in the intervention schools will receive a cash incentivised prevention program delivered by MIET Africa and the KwaZulu-Natal Department of Education
Receives: Behavioral: Cash incentives; Behavioral: Life skills curriculum

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HIV-incidence rates

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

    Measured: annually, after every 12 months of follow up

Secondary outcomes (7)

  1. 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.

    Measured: 6 monthly

  2. voluntary uptake of HIV testing

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

    Measured: annually, after every 12 months of follow up

  3. Substance use patterns

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

    Measured: annually, after every 12 months of follow up

  4. 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.

    Measured: annually, after every 12 months of follow up

  5. Contraceptive use patterns in female learners

    Annual behavioural questionnaires will monitor self-reported contraceptive use.

    Measured: annually, after every 12 months of follow up

  6. 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.

    Measured: annually, after every 12 months of follow up

  7. 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

    Measured: Annually, after every 12 months of follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Aug 2010 (estimated)
  2. Study startSep 2010
  3. Primary completionAug 2014
  4. Study completionAug 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
3,217 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01187979
Sponsor's protocol ID
CAPRISA 007
Acronym
RHIVA
Status last verified
Jan 2017
First submitted
12 Aug 2010
Last updated
19 Jan 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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. doi: 10.1097/01.aids.0000183129.16830.06.

    PubMed 16135907

  • 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. Epub 2008 Jun 15.

    PubMed 18558031

  • 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. doi: 10.1046/j.1365-3156.2002.00889.x.

    PubMed 12031070

  • Ayton SG, Pavlicova M, Abdool Karim Q. Identification of adolescent girls and young women for targeted HIV prevention: a new risk scoring tool in KwaZulu Natal, South Africa. Sci Rep. 2020 Aug 3;10(1):13017. doi: 10.1038/s41598-020-69842-x.

    PubMed 32747693

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cash incentives and Life skills curriculum in people with HIV Infections, run by Centre for the AIDS Programme of Research in South Africa at 1 site in South Africa.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HIV-incidence rates (time frame: annually, after every 12 months of follow up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01187979, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2017.

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Reducing HIV in Adolescents (NCT01187979) | AzTrials