Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Empower, Nudge: Increasing Dual Protection in South Africa (EN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02536612
Recruitment Status : Completed
First Posted : September 1, 2015
Last Update Posted : August 3, 2016
Sponsor:
Collaborator:
University of Cape Town
Information provided by (Responsible Party):
Omar Galarraga, Brown University

Brief Summary:
The purpose of the study is to test feasibility and acceptability of a lottery to help women in Cape Town, South Africa to continue using long-acting reversible contraceptives to avoid unintended pregnancies, and to also use condoms to reduce sexually transmitted infections including HIV.

Condition or disease Intervention/treatment Phase
HIV Pregnancy STDs Other: Lottery Other: No Lottery Not Applicable

Detailed Description:

The overall objective is to implement a pilot project offering conditional economic incentives (CEI) for dual protection (the prevention of HIV or other sexually transmitted infections and pregnancy via the simultaneous use of condoms plus effective contraception) among young women in Cape Town, South Africa, to test feasibility and acceptability, and to gather preliminary evidence on effect sizes to inform a future efficacy trial. CEI are an innovative structural approach for dual protection, which so far has not been tested in generalized HIV epidemic settings. The project has three aims. First, it will test the feasibility and acceptability of a conditional economic incentive (CEI) program to incentivize dual protection among young women in Cape Town. The working hypothesis is that a program with modest economic incentives in the form of a lottery to continue using modern contraception and stay free of sexually transmitted infections (STI) can be implemented among young women who express a desire to avoid unintended pregnancies. The hypothesis is that the CEI treatment group will exhibit greater program participation and retention rates as compared to the control group. Second, the study will obtain estimates of the effect of CEI on the primary outcomes (adherence to the dual protection regimen) through: (1) continuation of a contraceptive method of choice throughout the six month study period, and (2) self-reported condom use. Contraceptive continuation will be measured via clinic records (proxy for clinical checkup) at the 3 and 6 month follow up visits. Self-reported condom use will not be used to provide any incentives. The hypothesis is that receipt of CEI (lotteries) will be associated with higher rates of dual protection. Third, the study will examine the degree to which CEI (lotteries) impact secondary outcomes: a urine pregnancy test and STI status (measured at baseline and 6 month follow up). A selected STI (syphilis) will be monitored for assessment of the STI outcome, using a rapid test that can be administered at clinic level. The working hypothesis is that the participants in the CEI (lottery) treatment group will have reduced rates of STI and they will have lower rates of pregnancy.

This pilot trial will include young women, ages 18-40, recruited from a community clinic in Cape Town. A maximum of 96 women will be randomly assigned to one of two arms (n=48 each) in a randomized controlled trial design. In the trial, Arm 1 (control) will receive transport compensation for study visits at each of the study visits at baseline and at months 3 and 6. Arm 2 (intervention) will receive transport compensation for study visits at each visit at baseline and at months 3 and 6, plus the opportunity for entry in a lottery. Participants in Arm 2 will have a chance to receive two lottery tickets: (a) the first when returning by month 3, subject to confirmation of continued use of the participant's preferred contraceptive; (b) the second upon completion of the six month study period, subject to confirmation of continued use of the participant's preferred contraceptive over the course of the 6 month study period; and if they are free of a new curable STI. The lottery tickets will enter the participant into a drawing for a prize at month 3 and at the end of the six month study period. All participants will receive transport compensation each time at baseline, month 3 and month 6. There will be 15-20 minute follow-up sessions for everyone at months 3 and 6 when receiving STI results, and CEI (lotteries) for those in the treatment group. At month 3, follow-up sessions will include some reinforcement of key messages related to dual protection. At months 3 and 6, the follow-up sessions will include administration of the study questionnaire.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Empower, Nudge: Increasing Dual Protection Among Young Women in South Africa
Study Start Date : May 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Arm Intervention/treatment
Experimental: Lottery

Conditional economic incentive (CEI) lotto arm participants will get a chance to win a type of lottery or "lotto" ticket with a 50% chance of winning each time: (a) if they come back to the clinic and are still using a modern contraception method after 3 months (including IUD, injectable contraceptive, or implant); (b) if they come back to the clinic and are still using modern contraception after 6 months; and (c) if they come back to the clinic at 6 months and they don't have a new curable STD (such as syphilis).

They will also will receive reimbursement to cover their transport and time at baseline, at 3 months and at 6 months.

Other: Lottery
Opportunity for entry in lottery (each time, at months 3 and 6).
Other Name: Lotto; Empower Lotto Bowl

Active Comparator: No Lottery
Participants in the Control (No CEI Lotto) group will receive reimbursement to cover their transport and time at baseline, at 3 months and at 6 months; they will NOT have a chance to win a lottery even if they are still using a modern contraception and are free of new curable STDs.
Other: No Lottery
Transport compensation for study visits at baseline and at months 3 and 6. No chance to win lottery ticket.




Primary Outcome Measures :
  1. Retention in the study [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Long-acting contraceptive continuation [ Time Frame: 6 months ]
    continuation of a contraceptive method of choice throughout the six month study period

  2. Condom use [ Time Frame: 6 months ]
    Self-reported condom use (male and/or female)


Other Outcome Measures:
  1. Combined composite STDs [ Time Frame: 6 months ]
    Composite STDs (syphilis and HIV)



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Female
  • ages 18-40 years
  • Has been pregnant within the last 12 months (and has either delivered a baby, had a miscarriage, or an abortion within the last 12 months).
  • Has chosen one of the following contraceptive methods: IUD, Implant, or injectable

Exclusion Criteria:

  • Unwillingness to sign an informed consent to participate in research
  • Unwillingness to participate in the Control group, if so assigned in the randomization

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02536612


Locations
Layout table for location information
South Africa
Lady Michaelis Community Health Clinic
Cape Town, Western Cape, South Africa
Sponsors and Collaborators
Brown University
University of Cape Town
Investigators
Layout table for investigator information
Principal Investigator: Omar Galarraga, PhD Brown University School of Public Health
Principal Investigator: Abigail Harrison, PhD Brown University School of Public Health
Study Director: Jane Harries, PhD University of Cape Town
Additional Information:
Layout table for additonal information
Responsible Party: Omar Galarraga, Assistant Professor, Brown University
ClinicalTrials.gov Identifier: NCT02536612    
Other Study ID Numbers: IIA14-68
First Posted: September 1, 2015    Key Record Dates
Last Update Posted: August 3, 2016
Last Verified: August 2016
Keywords provided by Omar Galarraga, Brown University:
Motivation
Behavioral Economics
Conditional Economic Incentives
Conditional cash transfers
Contingency management