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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date November 2019
Source University of North Carolina, Chapel Hill
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

The evaluation assessed the effect of providing injectable and HIV risk counseling messages on contraceptive knowledge and uptake during a three month pilot intervention. The intervention was conducted September-November 2018 in ten healthcare facilities located in the Iringa and Njombe regions of Tanzania. Data collection for the evaluation occurred November-December 2018 and included 471 client exit interviews, 26 healthcare provider interviews, and the extraction of monthly aggregate service statistics for 12 months prior to the intervention and three months of the intervention. Univariate and bivariate analyses were used to assess quantitative interview data. Thematic qualitative assessment was used to assess qualitative interview data from healthcare providers. Interrupted time series analysis was used to assess changes in the trend of monthly contraceptive uptake.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Counseling messages on injectable use and HIV acquisition risk
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.

Locations

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

Sponsors (4)

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)

Country where clinical trial is conducted

Tanzania, 

Outcome

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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