Counseling on Injectable Contraception and HIV Risk in Tanzania

Contraception Clinical Trial

Official title:

Counseling on Injectable Contraception and HIV Risk: Evaluation of a Pilot Intervention in Tanzania

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04160169
• Other study ID #: 18-1049
• Status: Completed
• 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
• 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
• 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

Related Conditions & MeSH terms

• Contraception

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

External Links

•   Hormonal contraceptive eligibility for women at high risk of HIV: Guidance statement. 2017
•   Strategic communication framework for hormonal contraceptive methods and potential HIV-related risks. 2017.