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Home based human immunodeficiency virus (HIV) testing intervention in a rural community in South Africa
ISRCTN ISRCTN31271935
DOI 10.1186/ISRCTN31271935
ClinicalTrials.gov identifier
EudraCT number
Public title Home based human immunodeficiency virus (HIV) testing intervention in a rural community in South Africa
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 N/A
Serial number at source N/A
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.
Lay summary Not provided at time of registration
Ethics approval Medical Research Council Ethics Committee approval granted on the 25th May 2009 (ref: EC09-003)
Study design Community randomised controlled trial
Countries of recruitment South Africa
Disease/condition/study domain Human immunodeficiency virus
Participants - 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.
Participants - exclusion criteria 1. Inability to understand the intervention and provide informed consent
2. Children under 18 without parental consent
Anticipated start date 14/09/2009
Anticipated end date 15/12/2011
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 8 intervention clusters with 100 households in each cluster
Interventions 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.
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.
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.
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
Sources of funding 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)
Trial website
Publications 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23766483
Contact name Dr  Tanya  Doherty
  Address Health Systems Research Unit
Medical Research Council of South Africa
P.O Box 19070
Tygerberg
  City/town Cape Town
  Zip/Postcode 7505
  Country South Africa
  Email tanya.doherty@mrc.ac.za
Sponsor Centers for Disease Control and Prevention (South Africa)
  Address c/o Global AIDS Program/South Africa
877 Pretorius St.
Arcadia
  City/town Pretoria
  Zip/Postcode 0083
  Country South Africa
  Sponsor website: http://www.cdc.gov/
Date applied 25/08/2009
Last edited 14/08/2013
Date ISRCTN assigned 01/09/2009
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