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Completed

NCT Number: NCT04160169

Counseling on Injectable Contraception and HIV Risk 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.

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Key information

Conditions

Contraception

Age range

15 year–49 year

Sex eligibility

Female

Study type

Observational

Primary location

Ilula Hospital, Ilula, Iringa, Tanzania

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Positive HIV status known to healthcare provider

Treatment and study plan

Counseling messages on injectable use and HIV acquisition risk

Other

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.

Primary outcomes

  1. Number of clients obtaining an injectable during their family planning appointment

    Time frame: After implementation of counseling messages, up to 13 weeks

    Injectable uptake of interviewed clients

  2. Percent of clients obtaining an injectable during their family planning appointment

    Time frame: After implementation of counseling messages, up to 13 weeks

    Injectable uptake of interviewed clients

  3. Monthly total number of family planning clients by method obtained

    Time frame: September 2017 through November 2018

    Contraceptive uptake during pilot intervention

Secondary outcomes

  1. Number of correct hormonal contraception and HIV risk counseling messages mentioned during spontaneous recall

    Time frame: After implementation of counseling messages, up to 13 weeks

    Knowledge of hormonal contraception and HIV risk messages

  2. Percent of correct hormonal contraception and HIV risk counseling messages mentioned during spontaneous recall

    Time frame: After implementation of counseling messages, up to 13 weeks

    Knowledge of hormonal contraception and HIV risk messages

  3. Number of correct True/False statements on hormonal contraception and HIV (11 total)

    Time frame: After implementation of counseling messages, up to 13 weeks

    Knowledge of hormonal contraception and HIV risk messages

  4. Percent of correct True/False statements on hormonal contraception and HIV (11 total)

    Time frame: After implementation of counseling messages, up to 13 weeks

    Knowledge of hormonal contraception and HIV risk messages

  5. Number of interviewed clients reporting an intention to use condoms as a dual method

    Time frame: After implementation of counseling messages, up to 13 weeks

    Intention to use condoms as a dual method

  6. Percent of interviewed clients reporting an intention to use condoms as a dual method

    Time frame: After implementation of counseling messages, up to 13 weeks

    Intention to use condoms as a dual method

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • Johns Hopkins Bloomberg School of Public Health
  • Ministry of Health, Tanzania
  • United States Agency for International Development (USAID)

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Nov 12, 2019
Registry last updated
Nov 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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