Empower, Nudge: Increasing Dual Protection in South Africa

HIV Clinical Trial

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Official title:

Empower, Nudge: Increasing Dual Protection Among Young Women in South Africa

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02536612
• Other study ID #: IIA14-68
• Status: Completed
• Phase: N/A
• Start date: May 2015
• Est. completion date: June 2016

Study information

• Verified date: July 2021
• Source: Brown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV
• Pregnancy
• STDs

Intervention

Other:
• Lottery
Opportunity for entry in lottery (each time, at months 3 and 6).
• No Lottery
Transport compensation for study visits at baseline and at months 3 and 6. No chance to win lottery ticket.

Locations

Country	Name	City	State
South Africa	Lady Michaelis Community Health Clinic	Cape Town	Western Cape

Sponsors (2)

Lead Sponsor	Collaborator
Brown University	University of Cape Town

Country where clinical trial is conducted

South Africa, 

References & Publications (2)

Galárraga O, Harries J, Maughan-Brown B, Cooper D, Short SE, Lurie MN, Harrison A. The Empower Nudge lottery to increase dual protection use: a proof-of-concept randomised pilot trial in South Africa. Reprod Health Matters. 2018 Dec;26(52):1510701. doi: 1 — View Citation

Sullivan ME, Harrison A, Harries J, Sicwebu N, Rosen RK, Galárraga O. Women's reproductive decision making and abortion experiences in Cape Town, South Africa: A qualitative study. Health Care Women Int. 2018 Nov;39(11):1163-1176. doi: 10.1080/07399332.20 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Combined composite STDs	Composite STDs (syphilis and HIV)	6 months
Primary	Retention in the study		6 months
Secondary	Long-acting contraceptive continuation	continuation of a contraceptive method of choice throughout the six month study period	6 months
Secondary	Condom use	Self-reported condom use (male and/or female)	6 months

External Links

•   Women's Health Research Unit webpage