Trial record 2 of 9 for:    " November 26, 2006":" December 03, 2006"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

Male Partner Involvement in the Prevention of MTCT of HIV

This study has been completed.
Sponsor:
Collaborator:
University of Cape Town
Information provided by:
Imperial College London
ClinicalTrials.gov Identifier:
NCT00405990
First received: November 30, 2006
Last updated: May 8, 2008
Last verified: May 2008
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Optimizing the Impact of Prevention of Mother to Child Transmission of HIV in South Africa: the Forgotten Half of the Equation.

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • Percentage of partners agreeing to attend VCT. [ Time Frame: 12 weeks ]

Secondary Outcome Measures:
  • Percentage of partners and pregnant women abstaining, faithful to one partner and using condoms consistently. [ Time Frame: 12 weeks ]

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)
Intervention Details:
    Behavioral: Voluntary counselling and HIV testing in ANC for PMTCT
    VCT for 30 minutes in ANC
    Other Names:
    • ANC VCT
    • VCT for PMTCT
    Behavioral: VCT
    HIV VCT for PMTCT
    Other Name: VCT for PMTCT
Detailed Description:

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
Criteria

Inclusion Criteria:

  • To be eligible for participation, a woman must be less than 30 weeks pregnant at enrolment.

Exclusion Criteria:

  • Women who are more than 30 weeks pregnant will be excluded.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00405990

Locations
South Africa
Khayelitsha Midwive and Obstetric Unit Site B
Cape Town, Western Cape, South Africa, 7784
Sponsors and Collaborators
Imperial College London
University of Cape Town
Investigators
Principal Investigator: Boshishi K Mohlala, MBCHB FCOG MSC Imperial College London
  More Information

No publications provided by Imperial College London

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00405990     History of Changes
Other Study ID Numbers: cro625
Study First Received: November 30, 2006
Last Updated: May 8, 2008
Health Authority: South Africa: National Health Research Ethics Council

Keywords provided by Imperial College London:
HIV
MTCT
heterosexual behaviour
sexual risk behaviour
couple counselling
Voluntary counselling and testing
HIV Seronegativity

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on October 19, 2014