ContraceptionNCT04160169
Counseling on Injectable Contraception and HIV Risk in Tanzania
An observational study of Contraception, run by University of North Carolina, Chapel Hill at 10 sites in Tanzania.
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. Read more about this study
- Who is it for?
- Ages 15 to 49 years, women only
- Conditions the study is for
- Contraception
- What is being tested?
- Counseling messages on injectable use and HIV acquisition risk
- Type of treatment
- Injection or infusion
- How many people
- 10 participants
- Where
- 10 sitesTanzania
- Study dates
- 1 Sep 2018to 30 Nov 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 49 years
- Women only
- Child, Adult
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.
Who may be able to join
- Expressed interest in injectable use
- HIV-negative or unknown HIV status
Who cannot join
- Positive HIV status known to healthcare provider
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Tanzania10 sites
Ilula Hospital
Ilula, Iringa
Ihongole Health Center
Iringa
Ipogolo Health Center
Iringa
Kimande Health Center
Iringa
Mafinga Hospital
Mafinga, Iringa
Ipelele Health Center
Njombe
Kibena Regional Referral Hospital
Njombe
Makambako Hospital
Njombe
Makete Hospital
Njombe
Njombe Health Center
Njombe
About this study
Official title: 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.
Read the 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.
- Conditions
- Contraception
- Being tested
- Counseling messages on injectable use and HIV acquisition risk
- Keywords
- Counseling, Tanzania
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Counseling messages on injectable use and HIV acquisition riskOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of clients obtaining an injectable during their family planning appointment
Injectable uptake of interviewed clients
Measured: 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
Measured: After implementation of counseling messages, up to 13 weeks
Monthly total number of family planning clients by method obtained
Contraceptive uptake during pilot intervention
Measured: September 2017 through November 2018
Secondary outcomes (6)
Number of correct hormonal contraception and HIV risk counseling messages mentioned during spontaneous recall
Knowledge of hormonal contraception and HIV risk messages
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: After implementation of counseling messages, up to 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2019
- Study start1 Sep 2018
- Primary completion30 Nov 2018
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- United States Agency for International Development (USAID), Ministry of Health, Tanzania, Johns Hopkins Bloomberg School of Public Health
- Responsible party
- Sponsor
- Investigators
- Janine Barden-O'Fallon, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04160169
- Sponsor's protocol ID
- 18-1049
- Status last verified
- Nov 2019
- First submitted
- 7 Nov 2019
- Last updated
- 12 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data from the client interviews are publicly available through MEASURE Evaluation Dataverse in STATA format. The study report is also available on Dataverse.
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Counseling on Injectable Contraception and HIV Risk: Evaluation of a Pilot Intervention in Tanzania
- ClinicalTrials.gov ID
- NCT04160169
- Acronym / sponsor ID
- 18-1049
- Conditions
- Contraception
- Keywords
- Counseling, Tanzania
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- United States Agency for International Development (USAID), Ministry of Health, Tanzania, Johns Hopkins Bloomberg School of Public Health
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 12 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (2 listed)
- Expressed interest in injectable use
- HIV-negative or unknown HIV status
Key exclusion criteria (1 listed)
- Positive HIV status known to healthcare provider
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Counseling messages on injectable use and HIV acquisition riskCounseling 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. | Other | – |
Primary outcome
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
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
Monthly total number of family planning clients by method obtained
Time frame: September 2017 through November 2018
Contraceptive uptake during pilot intervention
6 secondary outcomes
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
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
Number of correct True/False statements on hormonal contraception and HIV (11 total)
Time frame: After implementation of counseling messages, up to 13 weeks
Percent of correct True/False statements on hormonal contraception and HIV (11 total)
Time frame: After implementation of counseling messages, up to 13 weeks
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2019.
- Hormonal contraceptive eligibility for women at high risk of HIV: Guidance statement. 2017Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Deidentified data from the client interviews are publicly available through MEASURE Evaluation Dataverse in STATA format. The study report is also available on Dataverse.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janine Barden-O'Fallon, PhD principal investigator
University of North Carolina, Chapel Hill
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Contraception, run by University of North Carolina, Chapel Hill at 10 sites in Tanzania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of clients obtaining an injectable during their family planning appointment (time frame: After implementation of counseling messages, up to 13 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2019.