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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: PACTR
Last refreshed on: 29 April 2013
Main ID:  PACTR201109000318329
Date of registration: 24/09/2011
Primary sponsor: Human Sciences Research Council
Public title: Promoting Male Involvement to Improve PMTCT Uptake and Reduce Antenatal HIV Infection [retrospectively registered]
Scientific title: Promoting Male Involvement to Improve PMTCT Uptake and Reduce Antenatal HIV Infection
Date of first enrolment: 2010-12-13
Target sample size: 478
Recruitment status: Completed: recruitment & data analysis complete
URL:  HTTP://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?da=true&tno=PACTR201109000318329
Study type:  interventional
Study design:  Factorial: participants randomly allocated to either no,one,some or all interventions simultaneously,
Randomised,
Permuted block randomisation: block size=12 community health centers matched by patient volume,
Allocation was determined by the holder of the sequence who is situated off site,
 
Countries of recruitment
South Africa
Contacts
Name: Karl  Peltzer
Address:  134 Pretorius Street 0002 Pretoria South Africa
Telephone: 012-3022000
Email: kpeltzer@hsrc.ac.za
Affiliation:  Research Director/HSRC
Name: Karl  Peltzer
Address:  134 Pretorius Street 0002 Pretoria South Africa
Telephone: 012-3022000
Email: kpeltzer@hsrc.ac.za
Affiliation:  Research Director/HSRC
Key inclusion & exclusion criteria
Inclusion criteria: Inclusion criteria: Eligible participants will be male and female. Women: a) pregnant women age 18 and older who have received HCT at the ANC, b) willing to attend PartnerPlus or PMTCT visits with their male partners, c) male partners must also be available to participate and d) both partners must be willing to participate in the study. Men: a) men aged 18 and older who are partners of pregnant women enrolled in the study, b) willing to attend PartnerPlus or PMTCT visits with their female partners, c) female partners must also be enrolled in the study and available to participate. All participants will be current adult residents of Mpumalanga Province and agree to attend four group sessions, 2 psychosocial assessments and 1 three day post-delivery assessment (maternal and infant only - blood sample assessment).
Exclusion criteria: Exclusion Criteria: Women who are not currently pregnant or are unwilling to receive HCT are not eligible for this study. Women whose partners are not willing to participate are not eligible for this study. Men whose pregnant partners are unwilling to participate are not eligible for this study. Women and men who are not couples are not eligible to participate. Participants unable to provide informed consent will not be eligible.

Age minimum: 18 Year
Age maximum: 60 Year
Gender: Both
Health Condition(s) or Problem(s) studied

HIV/AIDS
null
Intervention(s)
Primary Outcome(s)
1) increasing male partner participation in the PMTCT process, 2) increasing male HCT, 3) increasing maternal and infant adherence to the overall PMTCT protocol,
Secondary Outcome(s)
increasing the use of sexual barriers and reducing HIV transmission to mothers during pregnancy.
Secondary ID(s)
Source(s) of Monetary Support
NIH
Secondary Sponsor(s)
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