Home-based voluntary human immunodeficiency virus (HIV) counselling and testing in Zambia

ISRCTN ISRCTN53353725
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

University of Zambia
School of Medicine
Department of Community Medicine
PO BOX 50110
Lusaka
PO BOX 50110
Zambia

Email ccmichelo@yahoo.com

Study information

Study designCommunity-randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typePrevention
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA 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 objectivesHome-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) studiedHuman immunodeficiency virus (HIV)
InterventionA 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 typeOther
Primary outcome measureUptake and acceptability of VCT, measured at baseline and with follow-up surveys.
Secondary outcome measuresChanges in sexual risk behaviour, stigma and life-events, measured at baseline and with follow-up surveys.
Overall study start date23/03/2009
Completion date31/12/2009

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants1400
Total final enrolment1694
Key inclusion criteriaHousehold members (either sex) aged 16 years and above in the 28 selected villages
Key exclusion criteria1. 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 enrolment23/03/2009
Date of final enrolment31/12/2009

Locations

Countries of recruitment

  • Zambia

Study participating centre

University of Zambia
Lusaka
PO BOX 50110
Zambia

Sponsor information

Swedish International Development Cooperation Agency (SIDA) (Sweden)
Research organisation

Valhallavägen 199
Stockholm
105 25
Sweden

Website http://www.sida.org
ROR logo "ROR" 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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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.