NCT02351362

Brief Summary

Given there is substantial loss to follow-up soon after delivery among HIV-positive pregnant women in South Africa, we will conduct a pilot study of an innovative approach to improve retention in care targeted to this specific population at high risk of drop-out. The problem of poor retention in care is well documented, but interventions to address the issue are lacking. In order to design an effective intervention that will be tested in a future randomized controlled trial, we will first complete preliminary research via a pilot study in order to determine the feasibility and acceptability of an incentive program (i.e., a supermarket voucher) to reduce loss to follow-up among HIV-positive women after delivery. The primary objective of this study is to determine the feasibility of a voucher incentive intervention aimed at improving retention in postpartum HIV care Secondary objectives include: a) to determine the efficacy of the intervention at increasing postpartum retention; b) to determine the acceptability of the intervention in terms of women's preferences for the intervention compared to other possible interventions; c) to assess differences in patient retention among women newly diagnosed with HIV vs. those who knew their HIV-positive status before pregnancy; and d) to assess differences in patient retention among women who initiated ART during pregnancy vs. those who were on ART before becoming pregnant. We will enroll up to 200 adult (≥18 years), pregnant, HIV-positive women attending antenatal care who have not previously enrolled in the study at Hikhensile Clinic, Johannesburg, South Africa. The study will be a prospective intervention cohort study with historical controls. Intervention subjects will receive a one-time supermarket voucher of R50 (about $5.00) for participants who return for at least one postpartum visit at the study clinic within 10 weeks of delivery.

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 Feb 2015

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 30, 2015

Completed
2 days until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

January 5, 2018

Status Verified

January 1, 2018

Enrollment Period

2.4 years

First QC Date

January 22, 2015

Last Update Submit

January 3, 2018

Conditions

Keywords

RetentionAttritionIncentivePregnant women

Outcome Measures

Primary Outcomes (1)

  • Number of participants who receive a voucher.

    Defined as each participant who qualifies for a voucher successfully receiving the voucher via electronic transfer.

    10 weeks

Study Arms (2)

Incentive Group

EXPERIMENTAL

A one-time supermarket voucher of R50 (about $5.00) for participants who return for at least one postpartum visit at the study clinic within 10 weeks of delivery

Behavioral: Incentive Group

Control Group

NO INTERVENTION

Standard of care

Interventions

Incentive GroupBEHAVIORAL

A one-time supermarket voucher of R50 (about $5.00) for participants who return for at least one postpartum visit at the study clinic within 10 weeks of delivery

Incentive Group

Eligibility Criteria

Age19 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult (≥18 years of age)
  • HIV-positive at the time of enrollment
  • Pregnant
  • Initiating ART on day of enrollment, or already initiated on ART
  • Willing and able to provide written informed consent for study participation and data collection
  • Able to speak and understand spoken English
  • Must possess a working cell phone during the enrollment visit
  • Not previously enrolled in the study

You may not qualify if:

  • \- Patient requests to be transfered to non-study site for HIV care and treatment on day of recruitment/enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HIV Clinic

Johannesburg, Gauteng, 02476, South Africa

Location

MeSH Terms

Conditions

Tooth Wear

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Officials

  • Matthew Fox, DSc

    Boston University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 22, 2015

First Posted

January 30, 2015

Study Start

February 1, 2015

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

January 5, 2018

Record last verified: 2018-01

Locations