Contraception BehaviorNCT03594305
From Obstacles to Opportunities for Family Planning in Tanzania
A study testing Educational seminar in people with Contraception Behavior, run by Weill Medical College of Cornell University at 1 site in Tanzania.
Trial summary
The investigators will conduct a cluster randomized trial to determine the effectiveness of an educational intervention for religious leaders in promoting uptake of family planning in Tanzania. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Contraception Behavior
- What is being tested?
- Educational seminar
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTanzania
- Study dates
- 20 Aug 2018to 2 Jun 2022
- Phase
- Interventional
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Rural villages in northwest Tanzania with populations between 8,000 and 20,000
- Village dispensaries present to measure uptake of family planning
- Located in close proximity (50 km or less) to another eligible village with which it can be paired
Who cannot join
- Private dispensaries at which family planning uptake would be missed
Trial locations and contacts
1 site in 1 country.
About this study
The investigators will conduct a cluster randomized trial to determine the effectiveness of an educational intervention for religious leaders in promoting uptake of family planning in Tanzania.
Read the detailed description
In this community randomized trial, the investigators will randomize 12 rural villages to receive an educational seminar for their religious leaders about family planning. The investigators will compare these uptake of family planning in these 12 villages with 12 matched villages whose religious leaders do not attend an educational seminar about family planning. The investigators will also determine women's reasons for seeking family planning at the village dispensaries..
Prior to the start of the trial, the study team will ensure that dispensaries in all villages in the trial will have a reliable supply of contraceptive options. To mitigate the effect of economic barriers and medication shortages on access to contraception, a dedicated medication supply team will make certain that all dispensaries remain well-stocked with standard contraceptives that are free from the Tanzanian Ministry of Health. These include oral contraceptive pills, implants, injections, copper intrauterine devices, and condoms.
Villages will be paired by proximity (within 50 kilometers of one another). Within the pair, one village will be randomly assigned, using a computer-generated algorithm, to receive the intervention of religiously- and culturally-informed teaching intervention about family planning for religious leaders. The other village will be the control village. Each intervention village will be followed, and its religious leaders mentored in groups, for 12 months after the start of the intervention. Mentorship groups of 25 leaders, led by the study team, will meet for 1 hour per month. The investigators will also conduct focus groups in both intervention and control villages to understand community perceptions of family planning.
- Conditions
- Contraception Behavior
- Being tested
- Educational seminar
- Medical subject headings
- Contraception Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational seminarBehavioural
Religious leaders will be invited to participate in a one-day seminar led by Tanzanian religious leaders and physicians. The religious, cultural, and medical aspects of family planning will be discussed and seminar attendees will be given ample time for group discussions.
| Study group | Role | What they receive |
|---|---|---|
| Educational Intervention Arm | Experimental | Villages randomized to this arm will receive a one-day educational seminar, which their religious leaders of all denominations will be invited to attend. The seminar will address religious, cultural, and medical aspects of family planning. Leaders who attend will also have the opportunity to participate in mentorship group discussions after the intervention. In addition, both villages will have standard teaching provided by nurses at dispensaries about family planning, and a continual supply of contraceptive options at dispensaries in all villages will be ensured. Receives: Behavioral: Educational seminar |
| Control arm | No intervention | Villages randomized to this arm will not receive the educational seminar. These villages will have standard teaching provided by nurses at dispensaries about family planning, and a continual supply of contraceptive options at dispensaries in all villages will be ensured. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uptake of family planning at village dispensaries
The investigators will measure the percent of the population seeking modern contraception.
Measured: 12 months
Secondary outcomes (3)
Pregnancy rates
The investigators will obtain pregnancy rates for the village stratified by age.
Measured: 12 months
Reasons for seeking family planning
Women seeking family planning will answer a short structured yes/no questionnaire to determine the sources from which they were encouraged to seek family planning.
Measured: 12 months
Couple-years of protection
The investigators will use the types of family planning accessed to calculate couple-years of protection per given population number, according to conversion numbers provided by USAID (https://www.usaid.gov/what-we-do/global-health/family-planning/couple-years-protection-cyp)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2018
- Study start20 Aug 2018
- Primary completion12 Dec 2021
- Study completion2 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Contraception BehaviorStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster randomized trial in which villages are randomized to receive or not to receive the intervention.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Fuller Theological Seminary, St. Paul College
- Responsible party
- Sponsor
- Investigators
- Jennifer A Downs, MD, PhD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03594305
- Sponsor's protocol ID
- 1605017246
- Status last verified
- Jan 2023
- First submitted
- 5 Jun 2018
- Last updated
- 31 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mwakisole AH, Lambert VJ, Nzali A, Aristide C, Laizer E, Cordeiro AA, Gregory L, Mwakisole N, Nicol CEW, Paul N, Kalluvya SE, Kihunrwa A, Downs DJ, Wamoyi J, Downs JA, Lee MH. Partnerships with religious leaders to promote family planning in rural Tanzania: an open-label, cluster randomised trial. Lancet Glob Health. 2023 Dec;11(12):e1943-e1954. doi: 10.1016/S2214-109X(23)00453-9.
PubMed 37973342
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- From Obstacles to Opportunities for Family Planning in Tanzania
- ClinicalTrials.gov ID
- NCT03594305
- Acronym / sponsor ID
- 1605017246
- Conditions
- Contraception Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Fuller Theological Seminary, St. Paul College
- Study start
- 20 Aug 2018 (actual)
- Primary completion
- 12 Dec 2021 (actual)
- Study completion
- 2 Jun 2022 (actual)
- First posted
- 20 Jul 2018 (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 investigators will conduct a cluster randomized trial to determine the effectiveness of an educational intervention for religious leaders in promoting uptake of family planning in Tanzania.
Detailed description
In this community randomized trial, the investigators will randomize 12 rural villages to receive an educational seminar for their religious leaders about family planning. The investigators will compare these uptake of family planning in these 12 villages with 12 matched villages whose religious leaders do not attend an educational seminar about family planning. The investigators will also determine women's reasons for seeking family planning at the village dispensaries..
Prior to the start of the trial, the study team will ensure that dispensaries in all villages in the trial will have a reliable supply of contraceptive options. To mitigate the effect of economic barriers and medication shortages on access to contraception, a dedicated medication supply team will make certain that all dispensaries remain well-stocked with standard contraceptives that are free from the Tanzanian Ministry of Health. These include oral contraceptive pills, implants, injections, copper intrauterine devices, and condoms.
Villages will be paired by proximity (within 50 kilometers of one another). Within the pair, one village will be randomly assigned, using a computer-generated algorithm, to receive the intervention of religiously- and culturally-informed teaching intervention about family planning for religious leaders. The other village will be the control village. Each intervention village will be followed, and its religious leaders mentored in groups, for 12 months after the start of the intervention. Mentorship groups of 25 leaders, led by the study team, will meet for 1 hour per month. The investigators will also conduct focus groups in both intervention and control villages to understand community perceptions of family planning.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Cluster randomized trial in which villages are randomized to receive or not to receive the intervention.
| Arm | Type | Receives |
|---|---|---|
| Educational Intervention Arm | Experimental | Behavioral: Educational seminarVillages randomized to this arm will receive a one-day educational seminar, which their religious leaders of all denominations will be invited to attend. The seminar will address religious, cultural, and medical aspects of family planning. Leaders who attend will also have the opportunity to participate in mentorship group discussions after the intervention. In addition, both villages will have standard teaching provided by nurses at dispensaries about family planning, and a continual supply of contraceptive options at dispensaries in all villages will be ensured. |
| Control arm | No intervention | –Villages randomized to this arm will not receive the educational seminar. These villages will have standard teaching provided by nurses at dispensaries about family planning, and a continual supply of contraceptive options at dispensaries in all villages will be ensured. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Rural villages in northwest Tanzania with populations between 8,000 and 20,000
- Village dispensaries present to measure uptake of family planning
- Located in close proximity (50 km or less) to another eligible village with which it can be paired
Key exclusion criteria (1 listed)
- Private dispensaries at which family planning uptake would be missed
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 |
|---|---|---|
| Educational seminarReligious leaders will be invited to participate in a one-day seminar led by Tanzanian religious leaders and physicians. The religious, cultural, and medical aspects of family planning will be discussed and seminar attendees will be given ample time for group discussions. | Behavioural | Educational Intervention Arm |
Primary outcome
Uptake of family planning at village dispensaries
Time frame: 12 months
The investigators will measure the percent of the population seeking modern contraception.
3 secondary outcomes
Pregnancy rates
Time frame: 12 months
Reasons for seeking family planning
Time frame: 12 months
Couple-years of protection
Time frame: 12 months
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 31 Jan 2023.
- Derived from this study: PubMed 37973342Mwakisole AH, Lambert VJ, Nzali A, Aristide C, Laizer E, Cordeiro AA, Gregory L, Mwakisole N, Nicol CEW, Paul N, Kalluvya SE, Kihunrwa A, Downs DJ, Wamoyi J, Downs JA, Lee MH. Partnerships with religious leaders to promote family planning in rural Tanzania: an open-label, cluster randomised trial. Lancet Glob Health. 2023 Dec;11(12):e1943-e1954. doi: 10.1016/S2214-109X(23)00453-9.
Related trials for Contraception Behavior
Recruiting
Estimating the Impact of Sexuality Education and Mobile Health Services on Reproductive Health and Empowerment Among Adolescents in Sierra Leone for the Family Planning Impact Lab
Reproductive Health, Sexual Health
Not yet recruitingObservational study
FLOW: Influence of the Menstrual Cycle on Alcohol Use in Women
Alcohol Use, Alcohol Consumption
Not yet recruiting
Impact of Gender-Transformative Interventions on Contraceptive Use and Reproductive Autonomy in Somalia
Contraceptive Behavior, Social Norms
Recruiting
Impact of Self-Care Family Planning Services on Health and Development in South Sudan (Family Planning Impact Lab)
Contraceptive Behavior, Self Administration
Recruiting
"Vasectomy: Right for Me?" Decision Support Tool
Vasectomy, Contraception
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.
Jennifer A Downs, MD, PhD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational seminar in people with Contraception Behavior, run by Weill Medical College of Cornell University at 1 site 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 3 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 31 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Uptake of family planning at village dispensaries (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03594305, which also lists 1 linked publication.
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 31 Jan 2023.