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Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834     Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za     Website: www.pactr.org

Trial no.: PACTR201109000318329 Date registered: 2011/09/24
TRIAL DESCRIPTION
Public title Promoting Male Involvement to Improve PMTCT Uptake and Reduce Antenatal HIV Infection [retrospectively registered]
Official scientific title Promoting Male Involvement to Improve PMTCT Uptake and Reduce Antenatal HIV Infection
Brief summary describing the background
and objectives of the trial
This study proposes to evaluate the impact of combining two evidence-based interventions: a couples risk reduction intervention with an evidence based medication adherence intervention to enhance male participation in combination with improving medication and PMTCT adherence in antenatal clinics (ANCs) to increase PMTCT overall reach and effectiveness. The study will use a group-randomized design, recruiting 240 couples from 12 clinics. Clinics will be randomly assigned to experimental
Type of trial RCT
Acronym (If the trial has an acronym then please provide) PartnerPlus
Disease(s) or condition(s) being studied HIV/AIDS ,
Purpose of the trial Prevention
Anticipated trial start date 2010-12-06
Actual trial start date 2010-12-13
Anticipated date of last follow up 2011-12-31
Actual date of last follow up
Anticipated target sample size (number of participants) 480   
Actual target sample size (number of participants) 478   
Recruitment status Completed: recruitment & data analysis complete
Secondary Ids Issuing authority/Trial register Links to Secondary ID

STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person
allocating the participants to the intervention arms
Masking If masking / blinding was used
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 Masking/blinding used

INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental group PartnerPlus: Couple risk reduction intervention 4 group 1.5 hour sessions 4 weeks Provision of theory-based couple HIV risk reduction intervention 240
Control group Usual care and health education 4 group 1.5 hour sessions 4 weeks Usual Care will receive the PMTCT protocol plus a time matched group administered presentation of non-HIV health education videos 240

ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Min age Max age Gender
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: 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. 18 Years 60 Years Both

ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval
Name of the ethics committee
Yes 2010/08/18 Human Sciences Research Council Ethics Committee
Ethics Committee Address
Street address City Postal code Country
134 Pretorius Street Pretoria 0002 South Africa

OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1) increasing male partner participation in the PMTCT process, 2) increasing male HCT, 3) increasing maternal and infant adherence to the overall PMTCT protocol, Participant assessments will include both biological (clinic data) and psychosocial assessments at study entry, post-PartnerPlus intervention, 32 weeks prior to delivery, immediately prior to delivery, 3 days post-delivery and 6 weeks post-delivery
Secondary Outcome increasing the use of sexual barriers and reducing HIV transmission to mothers during pregnancy. biological (clinic data) and psychosocial assessments at study entry, post-PartnerPlus intervention, 32 weeks prior to delivery, immediately prior to delivery, 3 days post-delivery and 6 weeks post-delivery.

RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Human Sciences Research Council 134 Pretorius Street Pretoria 0002 South Africa

FUNDING SOURCES
Name of source Street address City Postal code Country
NIH 9000 Rockville Pike Bethesda, Maryland 20892 United States of America

SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Human Sciences Research Council 134 Pretorius Street Pretoria 0002 South Africa Foundation

COLLABORATORS
Name Street address City Postal code Country
Deborah Jones NW 123RD ST MIAMI Miami 1625 United States of America
Karl Peltzer 134 Pretorius Street Pretoria 0002 South Africa
Stephen Weiss 4600 Rickenbacker Cswy Key Biscayne, FL 33149-1031 United States of America

CONTACT PEOPLE
Role Name Email Phone Fax
Principal Investigator Prof Deborah Jones DJones@med.miami.edu (305) 243-2601 (305) 243-2126
Street address City Postal code Country Position / Affiliation
7631 Center Bay Drive North Bay Village, FL 33141 33141 United States of America Professor/University of Miami
Role Name Email Phone Fax
Public Enquiries Prof Karl Peltzer kpeltzer@hsrc.ac.za 012-3022000 012-3022637
Street address City Postal code Country Position / Affiliation
134 Pretorius Street Pretoria 0002 South Africa Research Director/HSRC
Role Name Email Phone Fax
Scientific Enquiries Prof Karl Peltzer kpeltzer@hsrc.ac.za 012-3022000 012-3022637
Street address City Postal code Country Position / Affiliation
134 Pretorius Street Pretoria 0002 South Africa Research Director/HSRC