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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
2008 study design and baseline results in http://www.ncbi.nlm.nih.gov/pubmed/18778329
Publication citations
-
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.