Multilevel Family Planning Intervention

NCT04262882 | Completed Results DMC

• 1 other identifier: 1R21HD098523-01A1
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 2

Brief Summary

This study seeks to develop and evaluate a multi-level intervention to satisfy couples' unmet need for family planning in rural Uganda. The study will evaluate the acceptability, feasibility, and preliminary efficacy of the intervention at increasing contraceptive uptake and continuation and improving intermediate outcomes of knowledge, attitudes, perceived community norms, partner communication and equity among couples in rural Uganda.

Conditions

Contraceptive Usage

Outcome Measures

Primary Outcomes (1)

• Number of Couples With Uptake of Any High Efficacy Contraceptive Method

  Uptake of any high efficacy contraceptive method. High efficacy contraceptive methods are defined based on efficacy for "typical use" of methods (rather than perfect use), inclusive of pills, injection, intrauterine device, implant, tubal ligation, vasectomy; measured through women's self-report and validated through clinic records and men's self-report

  7-months and 10-months follow-up

Secondary Outcomes (11)

• Number of Couples That Discontinued Use of a High Efficacy Contraceptive Method at 10-months Follow-up Among Those That Started Using a Method at 7-months Follow-up

  7 and 10 months follow-up

• Number of Couples With an Unintended Pregnancy

  10-months follow-up

• Change in Knowledge of Contraceptives

  Baseline, 7 and 10 months follow-up

• Change in Family Planning Attitudes

  Baseline, 7 and 10 months follow-up

• Change in Perceived Family Planning Norms

  Baseline, 7 and 10 months follow-up

Study Arms (2)

Multilevel Family Planning Intervention

EXPERIMENTAL

A multi-level, community-based intervention delivered in groups of couples to increase contraceptive uptake, reduce discontinuation, and reduce the incidence of unintended pregnancy, and improve intermediate outcomes (knowledge, attitudes, norms, communication, equity).

Behavioral: Multilevel Family Planning Intervention

Time and attention-matched control

ACTIVE COMPARATOR

A community sanitation intervention delivered in groups of couples to increase at-home and community hygiene practices.

Behavioral: Time and attention matched control

Interventions

Multilevel Family Planning Intervention BEHAVIORAL

The intervention is comprised of community dialogues, or facilitated discussions, aimed to reshape community norms around gender roles, equity, and family size, and critically analyze the social and community influences of "family-wealth" and poverty with the overall goal of reconstructing individual attitudes and group norms on paths to/definitions of a "successful family" inclusive of family planning. Dialogues are enhanced to address knowledge, motivation, self-efficacy, and relationship dynamics, tailored to men and women. Sessions include both gender segregated and integrated groups with couples in the community.

Multilevel Family Planning Intervention

Time and attention matched control BEHAVIORAL

This intervention serves as the attention-matched control. The format and delivery will mirror that of the "Family Health = Family Wealth" intervention (i.e., number, timing, and duration of sessions). The focus of the intervention is on community sanitation and at-home hygiene (hand-washing, food preparation) following an intervention manual that was developed for community groups in Uganda.

Time and attention-matched control

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Being in a relationship and both partners providing written informed consent; women: age 18-40 (or emancipated minor); men: age 18-50; not currently using modern contraceptives and having never used a non-reversible method; one or both partners wanting to prevent pregnancy for at least the next year; living within the selected villages; Luganda speaking.

You may not qualify if:

• Pregnant; Breastfeeding; Using a modern contraceptive method

Sponsors & Collaborators

• The University of Texas at San Antonio: lead
• Makerere University: collaborator
• San Diego State University: collaborator
• Yale University: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (2)

Katende Villages

Gombe, Butambala, Uganda

Location

Kyabadaza Villages

Gombe, Butambala, Uganda

Location

Related Publications (2)

• Sileo KM, Muhumuza C, Tuhebwe D, Munoz S, Wanyenze RK, Kershaw TS, Sekamatte S, Lule H, Kiene SM. "The burden is upon your shoulders to feed and take care of your children, not religion or culture": qualitative evaluation of participatory community dialogues to promote family planning's holistic benefits and reshape community norms on family success in rural Uganda. Contracept Reprod Med. 2024 Jun 4;9(1):28. doi: 10.1186/s40834-024-00290-y.

  PMID: 38835058 DERIVED

• Sileo KM, Muhumuza C, Sekamatte S, Lule H, Wanyenze RK, Kershaw TS, Kiene SM. The "Family Health = Family Wealth" intervention: study protocol for a pilot quasi-experimental controlled trial of a multi-level, community-based family planning intervention for couples in rural Uganda. Pilot Feasibility Stud. 2022 Dec 24;8(1):265. doi: 10.1186/s40814-022-01226-6.

  PMID: 36564852 DERIVED

MeSH Terms

Conditions

Contraception Behavior

Interventions

Time

Condition Hierarchy (Ancestors)

Reproductive Behavior; Behavior

Intervention Hierarchy (Ancestors)

Physical Phenomena

Limitations and Caveats

This was a pilot quasi-experimental controlled trial with the primary aims of establishing acceptability, feasibility, and preliminary effects of the intervention on the main and secondary outcomes. Thus, the intervention needs to be tested in a fully powered cluster randomized controlled trial to establish intervention efficacy.

Results Point of Contact

• Title: Dr. Katelyn Sileo
• Organization: University of Texas at San Antonio

katelyn.sileo@utsa.edu

210-458-7900

Study Officials

• Katelyn M Sileo, PhD, MPH

  University of Texas at San Antonio

  PRINCIPAL INVESTIGATOR

• Susan M Kiene, PhD, MPH

  San Diego State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2020
• First Posted: February 10, 2020
• Study Start: May 14, 2021
• Primary Completion: May 3, 2022
• Study Completion: March 1, 2023
• Last Updated: April 25, 2024
• Results First Posted: November 15, 2023

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 3 years after study completion for researchers and students within the collaborating institutions and 5 years after study completion for those outside of the collaborating institutions upon request
• Access Criteria: Upon request from the PI

Locations

UG (2)