Treating South African Pregnant Women for Methamphetamine

• Register: ClinicalTrials.gov
• Last refreshed on: 21 January 2013
• Main ID: NCT01386138
• Date of registration: 29/06/2011
• Primary sponsor: RTI International
• Public title: Treating South African Pregnant Women for Methamphetamine
• Scientific title: Treating South African Pregnant Women for Methamphetamine
• Date of first enrolment: July 2011
• Target sample size: 60
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT01386138
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Countries of recruitment

South Africa

Contacts

• Name: Hendree Jones, PhD
• Affiliation: RTI International

Key inclusion & exclusion criteria

Inclusion Criteria:

- are 18 years of age or older

- self-identify as "Coloured" (this is a cultural grouping of people with mixed-race
ancestry)

- live in the Cape Town township communities of Mitchell's Plain, Delft, Elsie's River,
Belhar, Bishop Lavis, or Ravensmead

- meet current DSM-IV criteria for methamphetamine abuse or dependence

- are willing to enter drug abuse treatment

- report unprotected sex in the past 30 days

- are HIV negative

- provide verifiable locator information for follow-up interview

- are 20-28 weeks pregnant, inclusive, and determined by last menstrual period

Exclusion Criteria:

- are male

- are younger than 18 years

- do not self-identify as "Coloured"

- do not live in the Cape Town township communities of Mitchell's Plain, Delft, Elsie's
River, Belhar, Bishop Lavis, or Ravensmead

- 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

- are HIV positive

- do not provide verifiable locator information for follow-up interview

- are not 20-28 weeks pregnant

- are not able to provide informed consent



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Drug Addiction

HIV

Intervention(s)

Behavioral: Experimental

Behavioral: Psycho-education

Primary Outcome(s)

Length of hospital stay [Time Frame: At time of delivery]

Methamphetamine practices [Time Frame: 3 months after randomization]

Prenatal care [Time Frame: At time of delivery]

Secondary Outcome(s)

Alcohol use [Time Frame: 3 months after randomization]

Birthweight [Time Frame: At time of delivery]

Drug and alcohol use composite scores [Time Frame: 3 months after randomization]

Drug Use [Time Frame: 3 months after randomization]

Estimated gestational age [Time Frame: At time of delivery]

Sexual practices [Time Frame: 3 months after randomization]

Secondary ID(s)

DA030565

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Cape Town