Clinical Trials Logo

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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02536612
Study type Interventional
Source Brown University
Contact
Status Completed
Phase N/A
Start date May 2015
Completion date June 2016

See also
  Status Clinical Trial Phase
Recruiting NCT06162897 - Case Management Dyad N/A
Completed NCT03999411 - Smartphone Intervention for Smoking Cessation and Improving Adherence to Treatment Among HIV Patients Phase 4
Completed NCT02528773 - Efficacy of ART to Interrupt HIV Transmission Networks
Active, not recruiting NCT05454839 - Preferences for Services in a Patient's First Six Months on Antiretroviral Therapy for HIV in South Africa
Recruiting NCT05322629 - Stepped Care to Optimize PrEP Effectiveness in Pregnant and Postpartum Women N/A
Completed NCT02579135 - Reducing HIV Risk Among Adolescents: Evaluating Project HEART N/A
Active, not recruiting NCT01790373 - Evaluating a Youth-Focused Economic Empowerment Approach to HIV Treatment Adherence N/A
Not yet recruiting NCT06044792 - The Influence of Primary HIV-1 Drug Resistance Mutations on Immune Reconstruction in PLWH
Completed NCT04039217 - Antiretroviral Therapy (ART) Persistence in Different Body Compartments in HIV Negative MSM Phase 4
Active, not recruiting NCT04519970 - Clinical Opportunities and Management to Exploit Biktarvy as Asynchronous Connection Key (COMEBACK) N/A
Completed NCT04124536 - Combination Partner HIV Testing Strategies for HIV-positive and HIV-negative Pregnant Women N/A
Recruiting NCT05599581 - Tu'Washindi RCT: Adolescent Girls in Kenya Taking Control of Their Health N/A
Active, not recruiting NCT04588883 - Strengthening Families Living With HIV in Kenya N/A
Completed NCT02758093 - Speed of Processing Training in Adults With HIV N/A
Completed NCT02500446 - Dolutegravir Impact on Residual Replication Phase 4
Completed NCT03805451 - Life Steps for PrEP for Youth N/A
Active, not recruiting NCT03902431 - Translating the ABCS Into HIV Care N/A
Completed NCT00729391 - Women-Focused HIV Prevention in the Western Cape Phase 2/Phase 3
Recruiting NCT05736588 - Elimisha HPV (Human Papillomavirus) N/A
Recruiting NCT03589040 - Darunavir and Rilpivirine Interactions With Etonogestrel Contraceptive Implant Phase 2