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: pactr.samrc.ac.za
Trial no.: PACTR201202000345423 Date of Approval: 20/01/2012
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Treating South African Pregnant Women for Methamphetamine
Official scientific title Treating South African Pregnant Women for Methamphetamine
Brief summary describing the background and objectives of the trial The purpose of this study is to develop and initially evaluate an efficacious, comprehensive, culturally sensitive, women-centered model of care for pregnant South African women by adapting and refining PI Jones' Reinforcement-Based Treatment (RBT) model, at the same time integrating into it the HIV prevention components of Co-I Wechsberg's Women's Health CoOp (WHC) model, yielding an integrated treatment and prevention model, RBT+WHC.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) The HOOP Study
Disease(s) or condition(s) being studied Methamphetamine use in pregnant women in South Africa,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/02/2012
Actual trial start date 15/01/2012
Anticipated date of last follow up 30/03/2013
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
Stellenbosch University Research Ethics Committee IRB00005239 and IRB00005240
12897 RTI International, Office of Research Protection, Institutional Review Board
NCT01386138 Clinicaltrials.gov
DA030565 National Institute on Drug Abuse
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
Parallel: different groups receive different interventions at same time during study Randomised Assignment to treatment is based on a computerized block randomization procedure (block = 2) Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group RBT+WHC 1 session x per week for 4 weeks 2 hours per session During the first hour of each session, the interventionist will present one of the four RBT+WHC modules topics. During the second hour of each session the participant will participate in the RBT intervention. 30
Control Group Psycho-education 1 session x per week for 4 weeks 2 hours per session Participants will meet with a counselor for a 2-hour session once per week for for weeks. During the first hour, the counselor will facilitate discussion of 1 of the 4 RBT+WHC module topics. The counselor will provide informatiton, but will not engage participants in active discussions. An informal case management session will occur during the second hour. 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Individuals who: Are 18 years of age or older Do not speak Afrikaans Live in the Cape Town township communities of Elsie¿s River or Ravensmead Meet current DSM-IV criteria for methamphetamine abuse or dependence Are willing to enter drug abuse treatment Report unprotected sex with a male partner in the past 30 days Are HIV negative Provide verifiable locator information for follow-up interview Are currently pregnant (verified by biological testing) Not be participating in any other pregnancy studies Individuals who: Are male Are younger than 18 years Do not speak Afrikaans Live in a place other than the specified Cape Town townships described in Inclusion criteria Do not meet current DSM-IV criteria for methamphetamine abuse or dependence Are not willing to enter drug abuse treatment Have not reported unprotected sex in the past 30 days HIV positive status Are not able to provide verifiable locator information for follow-up interview re not pregnant Are not able to provide informed consent 18 Year(s) 65 Year(s) Female
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 23/11/2011 Stellenbosch University Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Division for Research Development, 3rd Floor Admin Building B, Victoria Street Stellenbosch 7600 South Africa
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 22/07/2011 RTI International Office of Research Protection Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
3040 Cornwallis Road Research Triangle Park 27709 United States of America
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Methamphetamine practices Baseline 3 months after randomization
Primary Outcome Sexual practices Baseline 3 months after randomization
Primary Outcome Prenatal Care Time of delivery
Primary Outcome Neonatal Health Time of delivery
Secondary Outcome Drug use Baseline 3 months after randomization
Secondary Outcome Drug and alcohol use composite scores Baseline 3 months after randomization
Secondary Outcome Alcohol use Baseline 3 months after randomization
Secondary Outcome Sexual practices Baseline 3 months after randomization
Secondary Outcome Birthweight Time of delivery
Secondary Outcome Estimated gestational age Time of delivery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Elsies River CHC Halt Road Elsies River 7490 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
National Institute on Drug Abuse (NIDA) National Institute on Drug Abuse 6001 Executive Boulevard, Room 5213 Bethesda 20892-9561 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Medical Research Council Francie van Zijl Drive Parowvallei, Cape; PO Box 19070 Tygerberg 7505 South Africa Commercial Sector/Industry
Primary Sponsor RTI International 3040 Cornwallis Drive Research Triangle Park 27709 United States of America Commercial Sector/Industry
Secondary Sponsor Elsies River CHC Halt Road Elsies River 7490 South Africa Hospital
Secondary Sponsor Stellenbosch University Private Bag X1, Matieland Stellenbosch 7602 South Africa University
Secondary Sponsor University of Cape Town, South Africa University of Cape Town, Private Bag X3 Rondebosch 7701 South Africa University
COLLABORATORS
Name Street address City Postal code Country
University of Cape Town, South Africa University of Cape Town, Private Bag X3 Rondebosch 7701 South Africa
Medical Research Council Francie van Zijl Drive Parowvallei, Cape; PO Box 19070 Tygerberg 7505 South Africa
Elsies River CHC Halt Road Elsies River 7490 South Africa
Stellenbosch University Private Bag X1, Matieland Stellenbosch 7602 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hendree Jones hjones@rti.org 18003348571 3040 E Cornwallis Rd
City Postal code Country Position/Affiliation
Research Triangle Park, North Carolina 27709 United States of America Senior Research Psychologist, Substance Abuse Treatment Evaluations and Interventions
Role Name Email Phone Street address
Public Enquiries Hendree Jones hjones@rti.org 18003348571 3040 E Cornwallis Rd
City Postal code Country Position/Affiliation
Research Triangle Park, North Carolina 27709 United States of America Senior Research Psychologist, Substance Abuse Treatment Evaluations and Interventions
Role Name Email Phone Street address
Scientific Enquiries Hendree Jones hjones@rti.org 18003348571 3040 E Cornwallis Rd
City Postal code Country Position/Affiliation
Research Triangle Park, North Carolina 27709 United States of America Senior Research Psychologist, Substance Abuse Treatment Evaluations and Interventions
REPORTING
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Changes to trial information