HIV/AIDSNCT04307433
Storytelling Intervention to Promote Cervical Cancer Screening Uptakes Among Malawian Women Living With Human Immunodeficiency Virus
A study testing Storytelling narrative videos on tablets in people with HIV/AIDS, run by University of Massachusetts, Boston at 1 site in Malawi.
Trial summary
To develop a theory-based culturally-grounded storytelling-based intervention to increase cervical cancer screening among Malawian women living with HIV infection. Secondary objectives: To conduct a pilot randomized clinical trial (RCT) to examine the acceptability, feasibility and preliminary effectiveness of… Read more about this study
- Who is it for?
- Ages 20 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- Storytelling narrative videos on tablets
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 179 participants
- Where
- 1 siteMalawi
- Study dates
- 21 Oct 2021to 31 Aug 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 20 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women who:
- are confirmed HIV positive based on medical records
- are women living with HIV infection support group members
- are ages 20-50 years
- are no prior cervical cancer screening
- are no history of invasive cervical cancer
- are willingness to participate in the study
Who cannot join
- are not able to speak Chichewa or English
- self-report currently receiving treatment of a serious mental illness (e.g., schizophrenia and bipolar disorder)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: mHealth Delivered Narrative Intervention to Increase Cervical Cancer Screening Among Malawian Women Living With HIV
To develop a theory-based culturally-grounded storytelling-based intervention to increase cervical cancer screening among Malawian women living with HIV infection. Secondary objectives: To conduct a pilot randomized clinical trial (RCT) to examine the acceptability, feasibility and preliminary effectiveness of narrative intervention on cervical cancer screening prevention behavior.
Read the detailed description
Design
This two year project will employ a holistic community-based approach for recruitment. The project will involve two phases: Phase 1: The investigators will produce culturally-grounded and human-centered storytelling narrative intervention videos to address sociocultural and individual factors which influence cervical cancer prevention behaviors. Phase 2: The investigator will conduct a pilot RCT using the storytelling-based intervention delivered by mHealth (tablets) with 180 women residing in a rural community in Malawi. The intervention groups (Arm 1: storytelling narrative video on tablets [n=60] \& Arm 2: a video with a voice over presenting didactic materials on tablets [n=60]) will watch approximately 30 minutes of video intervention and the comparison group (Arm 3 [n=60]) will be read non-narrative educational materials. Study measures of attitudes, knowledge, and cervical cancer screening intention will be assessed by pre-test and immediate post-test interviews, then again at 2 and 6-months following the intervention.
Selection and Enrollment
Inclusion criteria are: 1) being confirmed HIV positive based on medical records, 2) women living with HIV infection (WLHIV) support group members, 3) ages 20-50 years, 4) no prior cervical cancer screening, 5) no history of invasive cervical cancer, and 6) willingness to participate in the study. The age range to 20-50 years for cervical cancer screening because there is limited evidence that this is the optimal upper age for cervical cancer screening of HIV-infected women (World Health Organization [WHO] 2013).
This study will use a sequential-stratified sampling method. Of the eligible support groups and among those expressing interest, the investigators will select 15 support groups from rural areas within the Lilongwe district and then randomly assign the selected groups into intervention and comparison arms. The computer-generated assignments will be stratified by support group size and the distance between intervention and control arms (at least 4 miles). Within each selected support group, 12 women who are eligible will be invited to participate in the study. The investigators have satisfactorily used these methods for recruitment of WLHIV by working with HIV support group leaders in our previous studies.
- Conditions
- HIV/AIDS
- Being tested
- Storytelling narrative videos on tablets
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Storytelling narrative videos on tabletsBehavioural
The storytelling narrative episodes in the application will feature video clips of the multiple stories of women living with HIV infection, HIV support group leaders, community leaders, and health care professionals and a Learn More video of physician discussing cervical cancer.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | ST Narrative + mHealth: Storytelling narrative video on tablets Receives: Behavioral: Storytelling narrative videos on tablets |
| Arm 2 | Active comparator | mHealth: a video with a voice over presenting didactic materials on tablets Receives: Behavioral: Storytelling narrative videos on tablets |
| Arm 3 | Placebo comparator | Control: non-narrative educational materials will be read Receives: Behavioral: Storytelling narrative videos on tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participant with Cervical Cancer Screening Uptakes
will be measured through self-report and health passport record review
Measured: six months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2020
- Study start21 Oct 2021
- Primary completion30 Jun 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The proposed study has two phases: Phase 1. Development of Narrative Video: The investigators will first develop culturally-grounded and human-centered storytelling narrative intervention videos in Chichewa, the local language to address sociocultural and individual factors which influence cervical cancer prevention behaviors. The video will be filmed in person in community organizations in Malawi. Phase 2: A Pilot Randomized Controlled Trial (RCT) of a Story Telling Narrative Intervention: The investigators will conduct a three-arm pilot RCT using the storytelling-based intervention delivered by mHealth (tablets) with 180 women residing in a rural community in Malawi. The intervention groups (Arm 1: storytelling narrative video on tablets \[n=60\] \& Arm 2: a video with a voice over presenting didactic materials on tablets \[n=60\]) will watch approximately 30 minutes of video intervention and the comparison group (Arm 3 \[n=60\]) will be read non-narrative educational materials
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Boston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haeok Lee, University of Massachusetts, Boston
- Investigators
- Haeok Lee, PhD, Principal investigator, University of Massachusetts, Boston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04307433
- Sponsor's protocol ID
- 2019250
- Status last verified
- Sep 2022
- First submitted
- 10 Mar 2020
- Last updated
- 30 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- mHealth Delivered Narrative Intervention to Increase Cervical Cancer Screening Among Malawian Women Living With HIV
- ClinicalTrials.gov ID
- NCT04307433
- Acronym / sponsor ID
- 2019250
- Conditions
- HIV/AIDS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- University of Massachusetts, BostonUniversity, hospital or other
- Study start
- 21 Oct 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 13 Mar 2020 (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.
To develop a theory-based culturally-grounded storytelling-based intervention to increase cervical cancer screening among Malawian women living with HIV infection. Secondary objectives: To conduct a pilot randomized clinical trial (RCT) to examine the acceptability, feasibility and preliminary effectiveness of narrative intervention on cervical cancer screening prevention behavior.
Detailed description
Design
This two year project will employ a holistic community-based approach for recruitment. The project will involve two phases: Phase 1: The investigators will produce culturally-grounded and human-centered storytelling narrative intervention videos to address sociocultural and individual factors which influence cervical cancer prevention behaviors. Phase 2: The investigator will conduct a pilot RCT using the storytelling-based intervention delivered by mHealth (tablets) with 180 women residing in a rural community in Malawi. The intervention groups (Arm 1: storytelling narrative video on tablets [n=60] \& Arm 2: a video with a voice over presenting didactic materials on tablets [n=60]) will watch approximately 30 minutes of video intervention and the comparison group (Arm 3 [n=60]) will be read non-narrative educational materials. Study measures of attitudes, knowledge, and cervical cancer screening intention will be assessed by pre-test and immediate post-test interviews, then again at 2 and 6-months following the intervention.
Selection and Enrollment
Inclusion criteria are: 1) being confirmed HIV positive based on medical records, 2) women living with HIV infection (WLHIV) support group members, 3) ages 20-50 years, 4) no prior cervical cancer screening, 5) no history of invasive cervical cancer, and 6) willingness to participate in the study. The age range to 20-50 years for cervical cancer screening because there is limited evidence that this is the optimal upper age for cervical cancer screening of HIV-infected women (World Health Organization [WHO] 2013).
This study will use a sequential-stratified sampling method. Of the eligible support groups and among those expressing interest, the investigators will select 15 support groups from rural areas within the Lilongwe district and then randomly assign the selected groups into intervention and comparison arms. The computer-generated assignments will be stratified by support group size and the distance between intervention and control arms (at least 4 miles). Within each selected support group, 12 women who are eligible will be invited to participate in the study. The investigators have satisfactorily used these methods for recruitment of WLHIV by working with HIV support group leaders in our previous studies.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- The proposed study has two phases: Phase 1. Development of Narrative Video: The investigators will first develop culturally-grounded and human-centered storytelling narrative intervention videos in Chichewa, the local language to address sociocultural and individual factors which influence cervical cancer prevention behaviors. The video will be filmed in person in community organizations in Malawi. Phase 2: A Pilot Randomized Controlled Trial (RCT) of a Story Telling Narrative Intervention: The investigators will conduct a three-arm pilot RCT using the storytelling-based intervention delivered by mHealth (tablets) with 180 women residing in a rural community in Malawi. The intervention groups (Arm 1: storytelling narrative video on tablets [n=60] \& Arm 2: a video with a voice over presenting didactic materials on tablets [n=60]) will watch approximately 30 minutes of video intervention and the comparison group (Arm 3 [n=60]) will be read non-narrative educational materials
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Behavioral: Storytelling narrative videos on tabletsST Narrative + mHealth: Storytelling narrative video on tablets |
| Arm 2 | Active comparator | Behavioral: Storytelling narrative videos on tabletsmHealth: a video with a voice over presenting didactic materials on tablets |
| Arm 3 | Placebo comparator | Behavioral: Storytelling narrative videos on tabletsControl: non-narrative educational materials will be read |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- are confirmed HIV positive based on medical records
- are women living with HIV infection support group members
- are ages 20-50 years
- are no prior cervical cancer screening
- are no history of invasive cervical cancer
Key exclusion criteria (2 listed)
- are not able to speak Chichewa or English
- self-report currently receiving treatment of a serious mental illness (e.g., schizophrenia and bipolar disorder)
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 |
|---|---|---|
| Storytelling narrative videos on tabletsThe storytelling narrative episodes in the application will feature video clips of the multiple stories of women living with HIV infection, HIV support group leaders, community leaders, and health care professionals and a Learn More video of physician discussing cervical cancer. | Behavioural | Arm 1, Arm 2, Arm 3 |
Primary outcome
Number of Participant with Cervical Cancer Screening Uptakes
Time frame: six months post-intervention
will be measured through self-report and health passport record review
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 30 Sep 2022.
- Individual participant dataSharing planned: No
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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.
Haeok Lee, PhD principal investigator
University of Massachusetts, Boston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Storytelling narrative videos on tablets in people with HIV/AIDS, run by University of Massachusetts, Boston at 1 site in Malawi.
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 2 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 30 Sep 2022. 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 Malawi. 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. Some participants in this study may receive a placebo. 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 Participant with Cervical Cancer Screening Uptakes (time frame: six months post-intervention). 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 30 Sep 2022.