Counseling on Injectable Contraception and HIV Risk in Tanzania

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

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.

Study Overview

• Status: Completed
• Conditions: Contraception
• Intervention / Treatment: Other: Counseling messages on injectable use and HIV acquisition risk

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• Tanzania
  • Iringa, Tanzania
    • Ihongole Health Center
  • Iringa, Tanzania
    • Ipogolo Health Center
  • Iringa, Tanzania
    • Kimande Health Center
  • Njombe, Tanzania
    • Ipelele Health Center
  • Njombe, Tanzania
    • Kibena Regional Referral Hospital
  • Njombe, Tanzania
    • Makambako Hospital
  • Njombe, Tanzania
    • Makete Hospital
  • Njombe, Tanzania
    • Njombe Health Center
  • Iringa
    • Ilula, Iringa, Tanzania
      • Ilula Hospital
    • Mafinga, Iringa, Tanzania
      • Mafinga Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 49 years (Child, Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

• Expressed interest in injectable use
• HIV-negative or unknown HIV status

Exclusion Criteria:

• Positive HIV status known to healthcare provider

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: Johns Hopkins Bloomberg School of Public Health; United States Agency for International Development (USAID); Ministry of Health, Tanzania
• Investigators: Principal Investigator: Janine Barden-O'Fallon, PhD, University of North Carolina, Chapel Hill

Publications and helpful links

Helpful 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Actual): November 30, 2018
• Study Completion (Actual): November 30, 2018

Study Registration Dates

• First Submitted: November 7, 2019
• First Submitted That Met QC Criteria: November 8, 2019
• First Posted (Actual): November 12, 2019

Study Record Updates

• Last Update Posted (Actual): November 12, 2019
• Last Update Submitted That Met QC Criteria: November 8, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Counseling; Tanzania
• Other Study ID Numbers: 18-1049

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified data from the client interviews are publicly available through MEASURE Evaluation Dataverse in STATA format. The study report is also available on Dataverse.
• IPD Sharing Time Frame: Data are currently available and will remain on Dataverse.org
• IPD Sharing Access Criteria: Site registration required.
• IPD Sharing Supporting Information Type: CSR

Study Data/Documents

1. Individual Participant Data Set
   Information identifier: doi:10.15139/S3/XEXQXO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No