Home-based voluntary human immunodeficiency virus (HIV) counselling and testing in Zambia
ISRCTN | ISRCTN53353725 |
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DOI | https://doi.org/10.1186/ISRCTN53353725 |
Secondary identifying numbers | N/A |
- Submission date
- 19/03/2009
- Registration date
- 30/04/2009
- Last edited
- 30/12/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Charles Michelo
Scientific
Scientific
University of Zambia
School of Medicine
Department of Community Medicine
PO BOX 50110
Lusaka
PO BOX 50110
Zambia
ccmichelo@yahoo.com |
Study information
Study design | Community-randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Other |
Study type | Prevention |
Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
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 |
Study objectives | 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(s) | 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) |
Health condition(s) or problem(s) studied | 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 |
Primary outcome measure | 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 study start date | 23/03/2009 |
Completion date | 31/12/2009 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 1400 |
Total final enrolment | 1694 |
Key inclusion criteria | Household members (either sex) aged 16 years and above in the 28 selected villages |
Key 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 |
Date of first enrolment | 23/03/2009 |
Date of final enrolment | 31/12/2009 |
Locations
Countries of recruitment
- Zambia
Study participating centre
University of Zambia
Lusaka
PO BOX 50110
Zambia
PO BOX 50110
Zambia
Sponsor information
Swedish International Development Cooperation Agency (SIDA) (Sweden)
Research organisation
Research organisation
Valhallavägen 199
Stockholm
105 25
Sweden
Website | http://www.sida.org |
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https://ror.org/01fn7me06 |
Funders
Funder type
Research organisation
Swedish International Development Cooperation Agency (SIDA) (Sweden)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Results article | results | 01/06/2013 | 30/12/2020 | Yes | No |
Editorial Notes
30/12/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.