Empower, Nudge: Increasing Dual Protection in South Africa
Condition: HIV; Pregnancy; STDs
Study type: Interventional

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.
    

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.
    

Intervention name(s): Lottery; No Lottery
Intervention type(s): Other; Other
Intervention description(s): Opportunity for entry in lottery (each time, at months 3 and 6).; Transport compensation for study visits at baseline and at months 3 and 6. No chance to win lottery ticket.
Other intervention name(s): Lotto; Empower Lotto Bowl
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Motivation; Behavioral Economics; Conditional Economic Incentives; Conditional cash transfers; Contingency management