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Cervical CancerNCT05952141

Strategies to Close the Gap From Cervical Cancer Diagnosis to Treatment in Botswana

A study testing Clinic Outreach, Enhanced Outreach and Low-Touch Strategy in people with Cervical Cancer, run by Abramson Cancer Center at Penn Medicine at 3 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Investigators will test the effectiveness of adaptive strategies on timely adoption of cervical cancer treatment in Botswana using a pragmatic trial design. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Cervical Cancer
What is being tested?
Clinic Outreach, Enhanced Outreach and Low-Touch Strategy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
610 participants
Where
3 sitesin 2 countries
Study dates
1 Sep 2023to 31 Aug 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients will be eligible if they:
  • are biological females
  • are aged 18 or older
  • have pathology-confirmed invasive cervical cancer diagnosis
  • have pathology results evaluated at National Health Laboratory in Botswana
  • are citizens of Botswana
  • have no prior history of invasive cervical cancer

Who cannot join

  • Patients will be excluded if they:
  • are biological males or otherwise born without a cervix
  • are below the age of 18 due to the rarity of cervical cancer in this population
  • do not meet study inclusion criteria

Trial locations and contacts

3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Katharine Rendle, PhD,MSW,MPH contact

215-349- 5442

katharine.rendle@pennmedicine.upenn.edu

Hannah Toneff, MSW, MA contact

267-882-3186

hannah.toneff@pennmedicine.upenn.edu

3 sites in 2 countries

Botswana2 sites, 2 recruiting

  • Nyangabgwe Referral Hospital

    Francistown, North-East District

    Surbhi Grover, MD, 2672076977, surbhi.grover@pennmedicine.upenn.edu

    Irene Ramokate, ramokatei@bup.org.bw

    Recruiting

  • Princess Marina Hospital

    Gaborone

    Surbhi Grover, MD, MPH, Surbhi.Grover@pennmedicine.upenn.edu

    Surbhi Grover, MD, MPH

    Recruiting

Other trials in Botswana

United States1 site

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

    Active, not recruiting

Other trials in United States

About this study

Official title: Thibang Diphatlha: Testing Adaptive Strategies to Close the Gap From Cervical Cancer Diagnosis to Treatment in Botswana

Investigators will test the effectiveness of adaptive strategies on timely adoption of cervical cancer treatment in Botswana using a pragmatic trial design.

Read the detailed description

Investigators will test the effectiveness of adaptive strategies on timely adoption of cervical cancer treatment in Botswana using a hybrid (type III) and pragmatic Sequential Multiple Assignment Randomized Trial (SMART) design. The adaptive strategies are designed to target patient- and system-level determinants identified in preliminary data, including delayed communication of results, individual and structural barriers to accessing treatment, and suboptimal care coordination between referring and cancer treatment clinics. The strategies draw upon key principles in behavioral economics and are supported by systematic evidence of the effectiveness of nudge strategies in preventive, HIV, and cancer care. The overarching rationale for the study is that enhancing coordination, communication, and navigation through centralized outreach and nudge strategies will increase timely treatment adoption and be scalable and sustainable in the long-term.

Conditions
Cervical Cancer
Being tested
Clinic Outreach, Enhanced Outreach, Low-Touch Strategy, High-Touch Strategy
Keywords
Screening, Botswana, Treatment, Patient
Medical subject headings
Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Clinic OutreachBehavioural

    A member of the pathology team will contact the referring clinic to communicate the readiness of results.

  • Enhanced OutreachBehavioural

    A member of the pathology team will contact both the referring clinic and the patient directly to communicate the readiness of results.

  • Low-Touch StrategyBehavioural

    Patient will be sent asynchronous text messaging reminders related to the importance of timely care using framed messaging.

  • High-Touch StrategyBehavioural

    Patient will be sent asynchronous text messaging reminders related to the importance of timely care using framed messaging in combination with synchronous telephone-based patient navigation.

Study groups in NCT05952141
Study groupRoleWhat they receive
Stage 1 Clinic Outreach + Stage 2 Low TouchExperimentalAll participants receive direct clinic outreach to communicate readiness of results (stage 1). Participants who do not attend the clinic by 30 days (non-responders) will receive asynchronous text message reminders using framed messaging (stage 2).
Receives: Behavioral: Clinic Outreach; Behavioral: Low-Touch Strategy
Stage 1 Clinic Outreach + Stage 2 High TouchExperimentalAll participants receive direct clinic outreach to communicate readiness of results (stage 1). Participants who do not attend the clinic by 30 days (non-responders) will receive asynchronous text message reminders using framed messaging in combination with synchronous patient navigation (stage 2).
Receives: Behavioral: Clinic Outreach; Behavioral: High-Touch Strategy
Stage 1 Enhanced Outreach + Stage 2 Low-TouchExperimentalAll participants receive direct clinic outreach plus enhanced outreach to communicate readiness of results (stage 1). Participants who do not attend the clinic by 30 days (non-responders) will receive asynchronous text message reminders using framed messaging (stage 2).
Receives: Behavioral: Enhanced Outreach; Behavioral: Low-Touch Strategy
Stage 1 Enhanced Outreach + Stage 2 High-TouchExperimentalAll participants receive direct clinic outreach plus enhanced outreach to communicate readiness of results (stage 1). Participants who do not attend the clinic by 30 days (non-responders) will receive asynchronous text message reminders using framed messaging in combination with synchronous patient navigation.
Receives: Behavioral: Enhanced Outreach; Behavioral: High-Touch Strategy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adoption

    Defined as the initiation of cervical cancer treatment within 90 days of randomization.

    Measured: Within 90 days of randomization

Secondary outcomes (5)

  1. Fidelity

    Defined as completion of evidence-based cancer treatment according to international guidelines and measured using medical record data.

    Measured: 12 months after randomization

  2. Reach: First Appointment

    Defined by the proportion of patients who complete an initial treatment visit divided by those randomized

    Measured: 12 months after randomization

  3. Reach: First Stage

    Defined by the proportion of patients who complete an enhanced outreach phone call divided by those contacted.

    Measured: 12 months after randomization

  4. Reach: Second Stage

    Defined by the proportion of patients who complete a patient navigation phone call (high touch strategy) divided by those contacted.

    Measured: 12 months after randomization

  5. Reach: Results

    Defined by the proportion of patients with confirmation of results received divided by those randomized.

    Measured: 12 months after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2023
  2. Study start1 Sep 2023
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Aug 2027 (estimated)

Resources

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
Sequential
Model description
Pragmatic Sequential Multiple Assignment Randomized Trial (SMART). This study uses a sequential randomization design in which all eligible participants will be randomized into one of two interventions at Stage 1 and then participants that do not respond to Stage 1 interventions will be randomized to receive Stage 2 interventions
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
610 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05952141
Sponsor's protocol ID
UPCC 23822
Other IDs
U01CA275032-01
Status last verified
Jul 2026
First submitted
11 Jul 2023
Last updated
22 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Rendle KA, Ramogola-Masire D, Grover S; Thibang Diphatlha Collective. Thibang Diphatlha: a sequential multiple assignment randomized trial designed to increase timely adoption of cervical cancer treatment in Botswana. Implement Sci Commun. 2024 Nov 12;5(1):128. doi: 10.1186/s43058-024-00659-9.

    PubMed 39533437

Questions about this trial

What is this clinical trial studying?

A study testing Clinic Outreach, Enhanced Outreach and Low-Touch Strategy in people with Cervical Cancer, run by Abramson Cancer Center at Penn Medicine at 3 sites in 2 countries.

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 7 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Botswana, United States. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Katharine Rendle, PhD,MSW,MPH (215-349- 5442, katharine.rendle@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adoption (time frame: Within 90 days of randomization). 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 NCT05952141, 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 22 Jul 2026.

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