Contact information
Type
Scientific
Primary contact
Dr Charles Michelo
ORCID ID
Contact details
University of Zambia
School of Medicine
Department of Community Medicine
PO BOX 50110
Lusaka
PO BOX 50110
Zambia
ccmichelo@yahoo.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
A community randomised trial on acceptability, feasibility, preventive impact and cost effectiveness of home-based voluntary human immunodeficiency virus (HIV) counselling and testing in Zambia
Acronym
Study hypothesis
Home-based voluntary human immunodeficiency virus (HIV) counselling and testing is more acceptable and gives higher uptake than clinic-based voluntary counselling and testing.
Ethics approval
1. University of Zambia Research Ethics Committee gave approval on the 26th March 2009 (ref: 007-12-08)
2. Regional Ethical Committee of Western Norway gave approval on the 26th February 2009 (ref: 024.09)
Study design
Community-randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Human immunodeficiency virus (HIV)
Intervention
A baseline survey will be conducted in 28 villages. 14 villages will be randomised to intervention (home-based voluntary HIV counselling and testing [VCT]) and a follow up survey will be conducted in both intervention and control villages after 6 months.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Uptake and acceptability of VCT, measured at baseline and with follow-up surveys.
Secondary outcome measures
Changes in sexual risk behaviour, stigma and life-events, measured at baseline and with follow-up surveys.
Overall trial start date
23/03/2009
Overall trial end date
31/12/2009
Reason abandoned
Eligibility
Participant inclusion criteria
Household members (either sex) aged 16 years and above in the 28 selected villages
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
1400
Participant exclusion criteria
1. Aged below 16 years
2. Not ordinary household members
3. People without full mental capacity
4. People under influence of alcohol or illegal drugs
Recruitment start date
23/03/2009
Recruitment end date
31/12/2009
Locations
Countries of recruitment
Zambia
Trial participating centre
University of Zambia
Lusaka
PO BOX 50110
Zambia
Sponsor information
Organisation
Swedish International Development Cooperation Agency (SIDA) (Sweden)
Sponsor details
Valhallavägen 199
Stockholm
105 25
Sweden
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Swedish International Development Cooperation Agency (SIDA) (Sweden)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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