Home based human immunodeficiency virus (HIV) testing intervention in a rural community in South Africa
| ISRCTN | ISRCTN31271935 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN31271935 |
| Secondary identifying numbers | N/A |
- 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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Dr Tanya Doherty
Scientific
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
| Study design | Community randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 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(s) | Medical Research Council Ethics Committee approval granted on the 25th May 2009 (ref: EC09-003) |
| 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 |
| Primary outcome measure | 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 study start date | 14/09/2009 |
| Overall study end date | 15/12/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 8 intervention clusters with 100 households in each cluster |
| 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 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
Study participating centre
Health Systems Research Unit
Cape Town
7505
South Africa
7505
South Africa
Sponsor information
Centers for Disease Control and Prevention (South Africa)
Government
Government
c/o Global AIDS Program/South Africa
877 Pretorius St.
Arcadia
Pretoria
0083
South Africa
| Website | http://www.cdc.gov/ |
|---|---|
"ROR" |
https://ror.org/042twtr12 |
Funders
Funder type
Government
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)
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 | 13/06/2013 | Yes | No |
