Condition category
Infections and Infestations
Date applied
19/03/2009
Date assigned
30/04/2009
Last edited
30/04/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.sida.org

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

Publication citations

Additional files

Editorial Notes