NCT02964169

Brief Summary

Supporting HIV positive women to delay or prevent an unwanted pregnancy may improve women's health through family planning choices, regular health reviews, and support. A cohort study that was done in Mbarara amongst HIV-infected women documented 50% of the enrolled women having no desire for a (another) child during the 4 years since ART initiation, 51% had a serodiscordant partner, with only 45% using effective contraceptive method. Key predictors of contraceptive use were family planning goals within the DYAD. One of the key predictors of effective contraceptive use was male partner involvement and CD4 count. The WHO recommends dual contraception (use of condoms and a hormonal or permanent method) to prevent both HIV transmission and unwanted pregnancies (WHO,2014).This prospective intervention study aims at providing information on whether continuous family planning accessibility and support has a measurable impact on pregnancy intentions and contraceptive usage among postpartum HIV positive mothers delivering at MRRH, SW Uganda.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
320

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2016

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

First Submitted

Initial submission to the registry

November 11, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 16, 2016

Completed
15 days until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

April 20, 2021

Status Verified

April 1, 2021

Enrollment Period

1.5 years

First QC Date

November 11, 2016

Last Update Submit

April 17, 2021

Conditions

HIV and Family Planning

Outcome Measures

Primary Outcomes (2)

  • Confirmed consistent use of an effective contraceptive method at 12 months

    12 months

  • Pregnancy desire/aspirations among the HIV positive women

    12 months

Study Arms (2)

Family Planning Support

EXPERIMENTAL

Family planning voucher and phone reminders

Behavioral: Family Planning Support

No Family Planning Support

NO INTERVENTION

Routine care

Interventions

Family Planning SupportBEHAVIORAL
Family Planning Support

Eligibility Criteria

Age18 Years - 48 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Mothers must be HIV positive
  • Have had a delivery within the last 48 hours
  • Above 18 years of age
  • Anticipating to begin family planning at 6 weeks postpartum
  • Must be mentally stable and qualify for any family planning methods available.

You may not qualify if:

  • Mothers who are HIV negative
  • Less than 18 years of age
  • Not anticipating to begin family planning at 6 weeks post partum
  • Mentally unstable or dont qualify for any family planning methods available.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mbarara Regional Referral Hospital

Mbarara, 00256, Uganda

Location

Related Publications (2)

  • Atukunda EC, Mugyenyi GR, Musiimenta A, Kaida A, Atuhumuza EB, Lukyamuzi EJ, Agaba AG, Obua C, Matthews LT. Structured and sustained family planning support facilitates effective use of postpartum contraception amongst women living with HIV in South Western Uganda: A randomized controlled trial. J Glob Health. 2021 Jun 5;11:04034. doi: 10.7189/jogh.11.04034.

    PMID: 34131487DERIVED

  • Atukunda EC, Mugyenyi GR, Obua C, Atuhumuza EB, Lukyamuzi EJ, Kaida A, Agaba AG, Matthews LT. Provision of family planning vouchers and early initiation of postpartum contraceptive use among women living with HIV in southwestern Uganda: A randomized controlled trial. PLoS Med. 2019 Jun 21;16(6):e1002832. doi: 10.1371/journal.pmed.1002832. eCollection 2019 Jun.

    PMID: 31226123DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 11, 2016

First Posted

November 16, 2016

Study Start

December 1, 2016

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

April 20, 2021

Record last verified: 2021-04

Locations

UG(1)