Condition category
Infections and Infestations
Date applied
06/04/2009
Date assigned
12/05/2009
Last edited
12/05/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Frances Cowan

ORCID ID

Contact details

Centre for Sexual Health and HIV Research
The Mortimer Market Centre
Off Capper Street
London
WC1E 6AU
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RO1 MH 65570

Study information

Scientific title

The Regai Dzive Shiri Project: a cluster randomised controlled trial to determine the effectiveness of a multi-component community-based human immunodeficiency virus (HIV) prevention intervention for rural youths in Zimbabwe

Acronym

The Regai Dzive Shiri Project

Study hypothesis

A community-based intervention targeting young people, adults and clinics will be effective in reducing rates of human immunodeficiency virus (HIV), herpes simplex virus type 2 (HSV-2) and pregnancy among young people in rural Zimbabwe.

Ethics approval

1. University College London (UCL) Ethics Committee approved on the 5th November 2002 (ref: 02/0140)
2. Medical Research Council of Zimbabwe approved on the 22nd October 2002 (ref: MRCZ/a/983)
3. London School of Hygiene and Tropical Medicine Ethics Committee approved on the 10th September 2002 (ref: 891)

Study design

Cluster randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

HIV prevention and reproductive health

Intervention

The intervention is theoretically based in social learning theory and the stages of change model. It aims to achieve change in societal norms within communities. The intervention has three components:
1. The youth programme for in- and out-of-school youths, is delivered by carefully selected and trained Zimbabwean school leavers in the year between leaving school and starting university. These school leavers work as volunteers and go to live and work in the rural communities for 8 - 10 months of the year. They act both as role models for young people and as a bridge between adults and youths within communities. These professional peer educators (PPEs) use well-structured, theoretically based materials which they deliver in a highly participatory way. The programme is delivered to all students and out-of-school youths who wanted to take part and not just those enrolled in the trial cohort.
2. The programme for parents and community stakeholders is a 22 session community-based programme that aims to improve knowledge about reproductive health, to improve communication between parents and their children and to improve community support for adolescent reproductive health. The community component arose from focus group discussions held with parents during the feasibility study. Parents lamented the collapse of traditional communication structures and acknowledged their lack of communication skills. Interestingly young people also said that they struggled to communicate with their parents especially about reproductive health issues and that they saw this as an important barrier to staying safe.
3. The programme for nurses and other staff working in rural health clinics aims to improve accessibility of clinics for out-of-school youth.

These three components are highly integrated. For example, nurses trained to run the clinic intervention also run sessions within the youth and parents programmes and in so doing publicise the accessibility of the clinic. PPEs help run the 'youth corners' at the clinics and help facilitate sessions in the parents programme. Integrating the three components in this way makes them mutually supportive and reinforcing. By living and working so closely with the community it is hypothesised that the PPEs are able to change the norms of that community through challenging the norms that may be detrimental to adolescent reproductive health and reinforcing those that are beneficial.

No specific intervention was introduced in the deferred intervention arm, but standard HIV prevention activities were implemented through the District AIDS Action Committees by local and international governmental and non-governmental organisations across both early and deferred intervention communities. The project provided voluntary HIV counselling and testing through rural health clinics in all 30 communities on one day a month for the duration of the study. Uptake and acceptability was recorded.

The intervention was introduced in 2003 in the early implementation arm and in 2007 in the delayed implementation arm. The intervention ran in the early implementation arm for four years from 2003 - 2007. The final evaluation survey was conducted in 2007 after 4 years of intervention delivery. The final evaluation survey was a representative population based survey of 18 - 22 year olds living in six purposively selected enumeration areas in the 30 study communities - i.e., 180 enumeration areas in all.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. HIV prevalence
2. HSV-2 prevalence

Measured in 2007 after 4 years of intervention delivery.

Secondary outcome measures

1. Pregnancy
2. Reported sexual behaviour
3. Knowledge and attitudes related to HIV acquisition and reproductive health

Measured in 2007 after 4 years of intervention delivery.

Overall trial start date

31/03/2003

Overall trial end date

31/07/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. For intervention: young people (aged 12 - 24 years, either sex) living in 15 early intervention implementation trial communities
2. For participation in final evaluation survey: all 18 - 22 year olds living in selected enumeration areas in trial communities

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

Intervention recipients n = 12,000 - 16,000; final evaluation survey n = 6,000

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

31/03/2003

Recruitment end date

31/07/2007

Locations

Countries of recruitment

Zimbabwe

Trial participating centre

Centre for Sexual Health and HIV Research
London
WC1E 6AU
United Kingdom

Sponsor information

Organisation

University College London (UCL) (UK)

Sponsor details

Gower Street
London
WC1E 6JD
United Kingdom
+44 (0)20 7380 9878
francesmcowan@yahoo.co.uk

Sponsor type

University/education

Website

http://ucl.ac.uk

Funders

Funder type

Government

Funder name

National Institute of Mental Health (NIMH) (USA) (ref: RO1 MH-65570-01 and RO1 MH-65570-4S)

Alternative name(s)

NIMH

Funding Body Type

government organisation

Funding Body Subtype

federal/national government

Location

United States of America

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2008 study design and baseline results in http://www.ncbi.nlm.nih.gov/pubmed/18778329

Publication citations

  1. Study design and baseline results

    Cowan FM, Pascoe SJ, Langhaug LF, Dirawo J, Chidiya S, Jaffar S, Mbizvo M, Stephenson JM, Johnson AM, Power RM, Woelk G, Hayes RJ, The Regai Dzive Shiri Project: a cluster randomised controlled trial to determine the effectiveness of a multi-component community-based HIV prevention intervention for rural youth in Zimbabwe--study design and baseline results., Trop. Med. Int. Health, 2008, 13, 10, 1235-1244, doi: 10.1111/j.1365-3156.2008.02137.x.

Additional files

Editorial Notes