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 design	Community-randomised controlled trial
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
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

Sponsor information

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

Valhallavägen 199
Stockholm
105 25
Sweden

Website	http://www.sida.org
"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 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.