Counseling on Injectable Contraception and HIV Risk in Tanzania
1 other identifier
observational
10
1 country
10
Brief Summary
The main objective of the evaluation was to assess the effect of providing injectable and HIV risk counseling messages on contraceptive knowledge and behavior during a three month pilot intervention in ten healthcare facilities in Tanzania.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Sep 2018
Shorter than P25 for all trials
10 active sites
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
Study Start
First participant enrolled
September 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2018
CompletedFirst Submitted
Initial submission to the registry
November 7, 2019
CompletedFirst Posted
Study publicly available on registry
November 12, 2019
CompletedNovember 12, 2019
November 1, 2019
3 months
November 7, 2019
November 8, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Number of clients obtaining an injectable during their family planning appointment
Injectable uptake of interviewed clients
After implementation of counseling messages, up to 13 weeks
Percent of clients obtaining an injectable during their family planning appointment
Injectable uptake of interviewed clients
After implementation of counseling messages, up to 13 weeks
Monthly total number of family planning clients by method obtained
Contraceptive uptake during pilot intervention
September 2017 through November 2018
Secondary Outcomes (6)
Number of correct hormonal contraception and HIV risk counseling messages mentioned during spontaneous recall
After implementation of counseling messages, up to 13 weeks
Percent of correct hormonal contraception and HIV risk counseling messages mentioned during spontaneous recall
After implementation of counseling messages, up to 13 weeks
Number of correct True/False statements on hormonal contraception and HIV (11 total)
After implementation of counseling messages, up to 13 weeks
Percent of correct True/False statements on hormonal contraception and HIV (11 total)
After implementation of counseling messages, up to 13 weeks
Number of interviewed clients reporting an intention to use condoms as a dual method
After implementation of counseling messages, up to 13 weeks
- +1 more secondary outcomes
Interventions
Counseling messages based on 2017 World Health Organization guidance, a review of the Strategic Communication Framework for Hormonal Contraceptive Methods and Potential HIV-related Risks, and the Family Planning Global Handbook were provided to clients expressing interest in injectables during regular family planning appointments.
Eligibility Criteria
All women attending a participating healthcare facility during the three month intervention period and who met eligibility criteria received the hormonal contraception and HIV risk messages.
You may qualify if:
- Expressed interest in injectable use
- HIV-negative or unknown HIV status
You may not qualify if:
- Positive HIV status known to healthcare provider
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Ilula Hospital
Ilula, Iringa, Tanzania
Mafinga Hospital
Mafinga, Iringa, Tanzania
Ihongole Health Center
Iringa, Tanzania
Ipogolo Health Center
Iringa, Tanzania
Kimande Health Center
Iringa, Tanzania
Ipelele Health Center
Njombe, Tanzania
Kibena Regional Referral Hospital
Njombe, Tanzania
Makambako Hospital
Njombe, Tanzania
Makete Hospital
Njombe, Tanzania
Njombe Health Center
Njombe, Tanzania
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
Janine Barden-O'Fallon, PhD
University of North Carolina, Chapel Hill
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 7, 2019
First Posted
November 12, 2019
Study Start
September 1, 2018
Primary Completion
November 30, 2018
Study Completion
November 30, 2018
Last Updated
November 12, 2019
Record last verified: 2019-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- CSR
- Time Frame
- Data are currently available and will remain on Dataverse.org
- Access Criteria
- Site registration required.
Deidentified data from the client interviews are publicly available through MEASURE Evaluation Dataverse in STATA format. The study report is also available on Dataverse.