Home based human immunodeficiency virus (HIV) testing intervention in a rural community in South Africa
| ISRCTN | ISRCTN31271935 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN31271935 |
| Protocol serial number | N/A |
| Sponsor | Centers for Disease Control and Prevention (South Africa) |
| Funder | 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) |
- Submission date
- 25/08/2009
- Registration date
- 01/09/2009
- Last edited
- 14/08/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
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 |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Community randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| 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 |
| Study objectives | 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(s) | Medical Research Council Ethics Committee approval granted on the 25th May 2009 (ref: EC09-003) |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
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. |
| Completion date | 15/12/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 800 |
| Key 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. |
| Key exclusion criteria | 1. Inability to understand the intervention and provide informed consent 2. Children under 18 without parental consent |
| Date of first enrolment | 14/09/2009 |
| Date of final enrolment | 15/12/2011 |
Locations
Countries of recruitment
- South Africa
Study participating centre
7505
South Africa
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | 13/06/2013 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |