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| Sponsors and Collaborators: |
Imperial College London University of Cape Town |
|---|---|
| Information provided by: | Imperial College London |
| ClinicalTrials.gov Identifier: | NCT00405990 |
Purpose
The study aims to invite male sexual partners to attend antenatal clinic with their pregnant partners to either acquire pregnancy information or undergo voluntary counselling and testing for HIV. To see if male sexual partner involvement will decrease sexual risk behaviour.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Behavioral: Voluntary counselling and HIV testing in ANC for PMTCT Behavioral: VCT |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Screening, Randomized, Open Label, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Optimizing the Impact of Prevention of Mother to Child Transmission of HIV in South Africa: the Forgotten Half of the Equation. |
| Estimated Enrollment: | 1000 |
| Study Start Date: | November 2006 |
| Study Completion Date: | May 2008 |
| Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
We will enrol 1000 pregnant women; recruited from antenatal clinic at Khayelitsha Midwive and Obstetric Unit (MOU). Community sensitization activities will be implemented in the catchment community to encourage male partner participation.
At the booking visit all women will be offered antenatal care, HIV group education and VCT as usual. Thereafter women will be recruited to enrol into the study, after signing the consent form half of the cohort members will be randomly assigned to partner VCT (Group A) and half to partner pregnancy information (Group B). Men in group B will be offered VCT at the second interview late in pregnancy. However, VCT will be provided if requested by study participants at any stage of the study or if the female partner is HIV positive. Women in group A will be given a written invitation to hand to their partners to encourage them to invite their partners to come to the antenatal clinic for VCT. In group B, women will be given a written invitation to give to their partners to encourage their partners to attend a pregnancy information session at the antenatal clinic.
VCT will be offered again close to delivery for all women and men who were previously uninfected or of unknown status. For those found to be HIV-infected at a prior visit, CD4 and CD8 T-cell counts, viral load, and full blood count tests will be conducted. Both women and men will be referred to the Antiretroviral clinic where ARV will be offered if appropriate and formula feeding (or exclusive breastfeeding) will be recommended. Reasons for declining VCT and data on sexual behaviour and violence will be sought at each visit.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| South Africa, Western Cape | |
| Khayelitsha Midwive and Obstetric Unit Site B | |
| Cape Town, Western Cape, South Africa, 7784 | |
| Principal Investigator: | Boshishi K Mohlala, MBCHB FCOG MSC | Imperial College London |
More Information
| Study ID Numbers: | cro625 |
| Study First Received: | November 30, 2006 |
| Last Updated: | May 8, 2008 |
| ClinicalTrials.gov Identifier: | NCT00405990 History of Changes |
| Health Authority: | South Africa: National Health Research Ethics Council |
|
HIV MTCT heterosexual behaviour sexual risk behaviour |
couple counselling Voluntary counselling and testing HIV Seronegativity |
|
Virus Diseases Sexually Transmitted Diseases, Viral HIV Antibodies HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
|
Virus Diseases Sexually Transmitted Diseases, Viral RNA Virus Infections Slow Virus Diseases Immune System Diseases HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Lentivirus Infections Infection Retroviridae Infections Immunologic Deficiency Syndromes |
