Contraception Clinical Trial
Official title:
Counseling on Injectable Contraception and HIV Risk: Evaluation of a Pilot Intervention in Tanzania
NCT number | NCT04160169 |
Other study ID # | 18-1049 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | September 1, 2018 |
Est. completion date | November 30, 2018 |
Verified date | November 2019 |
Source | University of North Carolina, Chapel Hill |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 10 |
Est. completion date | November 30, 2018 |
Est. primary completion date | November 30, 2018 |
Accepts healthy volunteers | |
Gender | Female |
Age group | 15 Years to 49 Years |
Eligibility |
Inclusion Criteria: - Expressed interest in injectable use - HIV-negative or unknown HIV status Exclusion Criteria: - Positive HIV status known to healthcare provider |
Country | Name | City | State |
---|---|---|---|
Tanzania | Ilula Hospital | Ilula | Iringa |
Tanzania | Ihongole Health Center | Iringa | |
Tanzania | Ipogolo Health Center | Iringa | |
Tanzania | Kimande Health Center | Iringa | |
Tanzania | Mafinga Hospital | Mafinga | 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 |
Lead Sponsor | Collaborator |
---|---|
University of North Carolina, Chapel Hill | Johns Hopkins Bloomberg School of Public Health, Ministry of Health, Tanzania, United States Agency for International Development (USAID) |
Tanzania,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | Monthly total number of family planning clients by method obtained | Contraceptive uptake during pilot intervention | September 2017 through November 2018 | |
Secondary | Number of correct hormonal contraception and HIV risk counseling messages mentioned during spontaneous recall | Knowledge of hormonal contraception and HIV risk messages | After implementation of counseling messages, up to 13 weeks | |
Secondary | Percent of correct hormonal contraception and HIV risk counseling messages mentioned during spontaneous recall | Knowledge of hormonal contraception and HIV risk messages | After implementation of counseling messages, up to 13 weeks | |
Secondary | Number of correct True/False statements on hormonal contraception and HIV (11 total) | Knowledge of hormonal contraception and HIV risk messages | After implementation of counseling messages, up to 13 weeks | |
Secondary | Percent of correct True/False statements on hormonal contraception and HIV (11 total) | Knowledge of hormonal contraception and HIV risk messages | After implementation of counseling messages, up to 13 weeks | |
Secondary | Number of interviewed clients reporting an intention to use condoms as a dual method | Intention to use condoms as a dual method | After implementation of counseling messages, up to 13 weeks | |
Secondary | Percent of interviewed clients reporting an intention to use condoms as a dual method | Intention to use condoms as a dual method | After implementation of counseling messages, up to 13 weeks |
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