Condition category
Infections and Infestations
Date applied
25/08/2009
Date assigned
01/09/2009
Last edited
14/08/2013
Prospective/Retrospective
Prospectively 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 Tanya Doherty

ORCID ID

Contact details

Health Systems Research Unit
Medical Research Council of South Africa
P.O Box 19070
Tygerberg
Cape Town
7505
South Africa
tanya.doherty@mrc.ac.za

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Good Start III: An effectiveness study of a home based voluntary counselling and testing (VCT) intervention in a rural community in South Africa

Acronym

Study hypothesis

Provision of home based human immunodeficiency virus (HIV) testing in intervention communities will result in increased HIV test acceptance, accelerated access to care and treatment for individuals testing HIV positive and reduced HIV risk behaviour compared to control communities.

Ethics approval

Medical Research Council Ethics Committee approval granted on the 25th May 2009 (ref: EC09-003)

Study design

Community randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Human immunodeficiency virus

Intervention

Offer of door to door VCT by trained community counsellors in a rural sub-district in KwaZulu-Natal South Africa. The total duration of the intervention will be 12 to 18 months. There is no cohort follow up. Outcomes will be assessed in a cross-sectional community based post-intervention survey in intervention and control arms 12 to 18 months following the start of the intervention.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Rates of HIV testing will be assessed in the post-intervention community survey in intervention and control arms. Questions to assess this outcome will include history of VCT, number of tests in the past year, and location/s where VCT was obtained. For each community, age and gender specific testing rates will be calculated.

Secondary outcome measures

1. Disclosure of HIV status: the post-intervention survey questions will ask about disclosure of serostatus to spouses, sexual partners and family members. The proportion of respondents reporting each disclosure type will be calculated.
2. Access to HIV care and treatment for individuals who are HIV positive: the post-intervention survey will have questions on access to HIV treatment for individuals testing HIV positive within the previous 12 to 18 months
3. HIV risk behaviour: HIV risk behaviours will be assessed using standardised questionnaire items that have been used previously in international settings. Risks include recent (one-month), intermediate (three-month) and longer-term (one-year), and lifetime measures of sexual behaviour (by partner gender, type of activity, condom use), using partner-by-partner elicitation (up to 5 individuals). We will include measures of relationship type (spouse, friend, casual acquaintance, commercial, etc). Algorithms will be developed to produce easily understood outcome measures (e.g., frequency of unprotected intercourse; proportion of acts using a condom).
4. Uptake of AZT and nevirapine amongst HIV positive pregnant women: women who have delivered a baby within the year prior to the post-intervention survey will be asked if they knew their HIV status and if they received AZT and nevirapine during pregnancy and labour

Overall trial start date

14/09/2009

Overall trial end date

15/12/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Individuals over 18 years of age, either sex
2. Living in a household in an intervention cluster
3. Providing informed consent. Children under the age of 18 will require parental consent for participation in the study and acceptance of VCT.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

8 intervention clusters with 100 households in each cluster

Participant exclusion criteria

1. Inability to understand the intervention and provide informed consent
2. Children under 18 without parental consent

Recruitment start date

14/09/2009

Recruitment end date

15/12/2011

Locations

Countries of recruitment

South Africa

Trial participating centre

Health Systems Research Unit
Cape Town
7505
South Africa

Sponsor information

Organisation

Centers for Disease Control and Prevention (South Africa)

Sponsor details

c/o Global AIDS Program/South Africa
877 Pretorius St.
Arcadia
Pretoria
0083
South Africa

Sponsor type

Government

Website

http://www.cdc.gov/

Funders

Funder type

Government

Funder name

Centers for Disease Control and Prevention Grants through President's Emergency Fund for AIDS Relief (PEPFAR) (USA) (grant refs: 1U51-PS000729-01; 1U2GPS001137-01; 5U2GPS001137-02)

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

2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23766483

Publication citations

  1. Results

    Doherty T, Tabana H, Jackson D, Naik R, Zembe W, Lombard C, Swanevelder S, Fox MP, Thorson A, Ekström AM, Chopra M, Effect of home based HIV counselling and testing intervention in rural South Africa: cluster randomised trial., BMJ, 2013, 346, f3481.

Additional files

Editorial Notes