NCT02536612

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P25-P50 for not_applicable hiv

Timeline
Completed

Started May 2015

Shorter than P25 for not_applicable hiv

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 20, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 1, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

July 23, 2021

Status Verified

July 1, 2021

Enrollment Period

1.1 years

First QC Date

August 20, 2015

Last Update Submit

July 19, 2021

Conditions

HIVPregnancySTDs

Keywords

MotivationBehavioral EconomicsConditional Economic IncentivesConditional cash transfersContingency management

Outcome Measures

Primary Outcomes (1)

  • Retention in the study

    6 months

Secondary Outcomes (2)

  • Long-acting contraceptive continuation

    6 months

  • Condom use

    6 months

Other Outcomes (1)

  • Combined composite STDs

    6 months

Study Arms (2)

Lottery

EXPERIMENTAL

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

No Lottery

ACTIVE COMPARATOR

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

Interventions

LotteryOTHER

Opportunity for entry in lottery (each time, at months 3 and 6).

Also known as: Lotto; Empower Lotto Bowl
Lottery
No LotteryOTHER

Transport compensation for study visits at baseline and at months 3 and 6. No chance to win lottery ticket.

No Lottery

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lady Michaelis Community Health Clinic

Cape Town, Western Cape, South Africa

Location

Related Publications (2)

  • Galarraga 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: 10.1080/09688080.2018.1510701.

    PMID: 30212281RESULT

  • Sullivan ME, Harrison A, Harries J, Sicwebu N, Rosen RK, Galarraga 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: 10.1080/07399332.2017.1400034. Epub 2017 Dec 15.

    PMID: 29111909RESULT

MeSH Terms

Conditions

Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Communicable DiseasesInfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Omar Galarraga, PhD

    Brown University School of Public Health

    PRINCIPAL INVESTIGATOR

  • Abigail Harrison, PhD

    Brown University School of Public Health

    PRINCIPAL INVESTIGATOR

  • Jane Harries, PhD

    University of Cape Town

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 20, 2015

First Posted

September 1, 2015

Study Start

May 1, 2015

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

July 23, 2021

Record last verified: 2021-07

Locations

ZA(1)