HIVNCT05033002

Efficacy Testing of a Culturally Relevant Stigma Intervention With WLWH in Tanzania

A study testing Labda Siku Moja stigma reduction intervention in people with HIV and Stigma, Social, run by Duke University at 1 site in Tanzania.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study will test a stigma reduction intervention with women living with HIV in Tanzania. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: HIV, Stigma, Social, Self Efficacy
What is being tested?: Labda Siku Moja stigma reduction intervention
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 167 participants
Where: 1 siteTanzania
Study dates: 24 Oct 2022to 28 May 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

The inclusion criteria for this study are:
(1) women who are living with HIV;
(2) age 18 (age of adulthood as defined by the Tanzanian government);
(3) able and willing to voluntarily consent to participate in the study;
(4) able to travel to a data collection in their local community (as described above);
(5) demonstrate mental competence at time of informed consent;
(6) verbally indicate that they plan to reside in their current community for at least 6 months after enrollment (necessary to prevent attrition);
(7) score at the median or higher level on the Swahili Version of the Multidimensional Measure of Internalized HIV Stigma Scale.

Who cannot join

(1) any acute psychological or physiological distress; if there is evidence of acute psychologic and/or physiologic, they will be excluded from this study and referred to an appropriate site for evaluation and treatment.
(2) Transgender women living with HIV will not be eligible to participate in this study to reduce the potential for confounding sources of stigma recognizing that a transgender identity is highly stigmatized and culturally sensitive in Tanzania. Further, it would be exceedingly difficult to recruit a sufficient sample of transgender women living with HIV to conduct an appropriate analysis.
(3) Participants may be enrolled in other HIV-related studies except cognitive-behavioral intervention studies addressing stigma, self-efficacy, self-esteem, and/or disclosure

Trial locations and contacts

1 site in 1 country.

Tanzania1 site

Muhimbili University of Health and Allied Sciences
Dar es Salaam

Other trials in Tanzania

About this study

Official title: Efficacy Testing of a Culturally Relevant Stigma Intervention With Women Living With HIV in Tanzania

This study will test a stigma reduction intervention with women living with HIV in Tanzania.

Read the detailed description

This study will test a culturally and linguistically relevant stigma reduction intervention, Labda Siku Moja, among women living with HIV in Tanzania.

Conditions: HIV, Stigma, Social, Self Efficacy, Self Esteem, Hope, Depressive Symptoms
Being tested: Labda Siku Moja stigma reduction intervention
Keywords: HIV, women living with HIV, clinical trial, Tanzania, efficacy, feasibility
Medical subject headings: Social Stigma, Depression

What participants receive

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

Labda Siku Moja stigma reduction interventionBehavioural
The Labda Siku Moja stigma reduction intervention is a tailored stigma reduction intervention for women living with HIV in Tanzania. It is comprised of five ethnodramas (video stories) culturally and linguistically relevant to the Tanzanian women living with HIV.

Study groups in NCT05033002
Study group	Role	What they receive
Treatment as Usual Group	No intervention	This group will receive treatment as usual which means that no formal stigma reduction intervention will be provided. At the end of the follow-up period, this group will be invited to view the Labda Siku Moja stigma reduction intervention without follow-up.
Stigma Intervention Group	Experimental	This group will participate in a 5 week intervention. Each week, intervention group participants will watch one ethnodrama segment of the Labda Siku Moja stigma reduction intervention followed by a guided debrief using motivational interviewing. Receives: Behavioral: Labda Siku Moja stigma reduction intervention

What is being measured

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

Number of Participants Recruited as Measured by Enrollment Logs
Measured: up to 6 months
Number of Study Participants Retained in Study as Measured by Enrollment Logs
Measured: 30, 90, and 180 days after intervention
Percent of Questions Left Blank on Study Instruments
Measured: baseline and 30, 90, and 180 days after intervention
Time it Takes in Minutes for Participants to Complete the Questionnaires
Measured: baseline and 30, 90, and 180 days after intervention
Number of Women Who Completed All 5 Sessions
Measured: up to 5 weeks

Secondary outcomes (5)

Change in Internalized Stigma, as Measured by the Swahili Version of the Multidimensional Measure of Internalized Stigma Scale
Scores range from 0 to 100 with lower scores indicating less stigma and higher scores indicating more stigma
Measured: baseline and 30, 90, and 180 days after intervention
Change in Coping Self-efficacy, as Measured by the Swahili Version of the Coping Self-Efficacy Scale
Scores range from 0 to 26, with lower scores indicating lower coping self-efficacy and higher scores indicating greater coping self-efficacy.
Measured: baseline and 30, 90, and 180 days after intervention
Change in Self-esteem, as Measured by the Swahili Version of the Rosenberg Self-Esteem Scale
Scores range from 10 to 40, with lower scores indicating lower self-esteem and higher scores indicating higher self-esteem
Measured: baseline and 30, 90, and 180 days after intervention
Hope, as Measured by the Swahili Version of the State of Hope Scale
Scores range from 6 to 24, with lower scores indicating less hope and higher scores indicating more hope
Measured: Baseline
Change in Depressive Symptoms, as Measured by the Swahili Version of the Patient Health Questionnaire 9
Scores range from 0 to 27, with lower scores indicating less depressive symptoms and higher scores indicating more depressive symptoms
Measured: baseline and 30, 90, and 180 days after intervention

Timeline

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

24 Oct 202228 May 2024

First posted2 Sep 2021
Study start24 Oct 2022
Primary completion16 May 2024
Study completion28 May 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HIVStudies of the same condition, open and under way.
More trials run by Duke 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: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 167 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05033002
Sponsor's protocol ID: Pro00109278
Status last verified: May 2025
First submitted: 31 Aug 2021
Last updated: 29 May 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Nyblade L, Kilonzo MN, Kisamo DH, Mtei RJ, Pan W, Relf MV. Efficacy Testing of a Culturally Relevant Stigma Reduction Intervention for Women Living With HIV in Tanzania: Protocol for a Randomized Controlled Trial. J Assoc Nurses AIDS Care. 2025 Mar 26;36(5):470-481. doi: 10.1097/JNC.0000000000000538.
PubMed 40138392

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All HIV trials

Study at a glance

From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy Testing of a Culturally Relevant Stigma Intervention With Women Living With HIV in Tanzania
ClinicalTrials.gov ID: NCT05033002
Acronym / sponsor ID: Pro00109278
Conditions: HIV, Stigma, Social, Self Efficacy, Self Esteem, Hope, Depressive Symptoms
Keywords: HIV, women living with HIV, clinical trial, Tanzania, efficacy, feasibility
Study type: Interventional
Recruitment status: Completed
Enrolment: 167 participants (actual)
Lead sponsor: Duke UniversityUniversity, hospital or other
Collaborators: Muhimbili University of Health and Allied Sciences, RTI International
Study start: 24 Oct 2022 (actual)
Primary completion: 16 May 2024 (actual)
Study completion: 28 May 2024 (actual)
First posted: 2 Sep 2021 (actual)
Results: Posted 29 May 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study will test a stigma reduction intervention with women living with HIV in Tanzania.

Detailed description

This study will test a culturally and linguistically relevant stigma reduction intervention, Labda Siku Moja, among women living with HIV in Tanzania.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Treatment as Usual Group	No intervention	–This group will receive treatment as usual which means that no formal stigma reduction intervention will be provided. At the end of the follow-up period, this group will be invited to view the Labda Siku Moja stigma reduction intervention without follow-up.
Stigma Intervention Group	Experimental	Behavioral: Labda Siku Moja stigma reduction interventionThis group will participate in a 5 week intervention. Each week, intervention group participants will watch one ethnodrama segment of the Labda Siku Moja stigma reduction intervention followed by a guided debrief using motivational interviewing.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

(1) women who are living with HIV;
(2) age 18 (age of adulthood as defined by the Tanzanian government);
(3) able and willing to voluntarily consent to participate in the study;
(4) able to travel to a data collection in their local community (as described above);
(5) demonstrate mental competence at time of informed consent;

Key exclusion criteria (3 listed)

(1) any acute psychological or physiological distress; if there is evidence of acute psychologic and/or physiologic, they will be excluded from this study and referred to an appropriate site for evaluation and treatment.
(2) Transgender women living with HIV will not be eligible to participate in this study to reduce the potential for confounding sources of stigma recognizing that a transgender identity is highly stigmatized and culturally sensitive in Tanzania. Further, it would be exceedingly difficult to recruit a sufficient sample of transgender women living with HIV to conduct an appropriate analysis.
(3) Participants may be enrolled in other HIV-related studies except cognitive-behavioral intervention studies addressing stigma, self-efficacy, self-esteem, and/or disclosure

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
Labda Siku Moja stigma reduction interventionThe Labda Siku Moja stigma reduction intervention is a tailored stigma reduction intervention for women living with HIV in Tanzania. It is comprised of five ethnodramas (video stories) culturally and linguistically relevant to the Tanzanian women living with HIV.	Behavioural	Stigma Intervention Group

Primary outcome

Number of Participants Recruited as Measured by Enrollment Logs
Time frame: up to 6 months
Number of Study Participants Retained in Study as Measured by Enrollment Logs
Time frame: 30, 90, and 180 days after intervention
Percent of Questions Left Blank on Study Instruments
Time frame: baseline and 30, 90, and 180 days after intervention
Time it Takes in Minutes for Participants to Complete the Questionnaires
Time frame: baseline and 30, 90, and 180 days after intervention
Number of Women Who Completed All 5 Sessions
Time frame: up to 5 weeks

5 secondary outcomes

Change in Internalized Stigma, as Measured by the Swahili Version of the Multidimensional Measure of Internalized Stigma Scale
Time frame: baseline and 30, 90, and 180 days after intervention
Change in Coping Self-efficacy, as Measured by the Swahili Version of the Coping Self-Efficacy Scale
Time frame: baseline and 30, 90, and 180 days after intervention
Change in Self-esteem, as Measured by the Swahili Version of the Rosenberg Self-Esteem Scale
Time frame: baseline and 30, 90, and 180 days after intervention
Hope, as Measured by the Swahili Version of the State of Hope Scale
Time frame: Baseline
Change in Depressive Symptoms, as Measured by the Swahili Version of the Patient Health Questionnaire 9
Time frame: baseline and 30, 90, and 180 days after intervention

Results and safety

Results posted to the registry on 29 May 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment as Usual Group	80	80
Stigma Intervention Group	87	78

Primary outcome: Number of Participants Recruited as Measured by Enrollment Logs

Time frame: up to 6 months. Count of participants. Unit: Participants

Measure	Treatment as Usual Group n = 80	Stigma Intervention Group n = 87
Value	80	87

Primary outcome: Number of Study Participants Retained in Study as Measured by Enrollment Logs

Time frame: 30, 90, and 180 days after intervention. Count of participants. Unit: Participants

Measure	Treatment as Usual Group n = 80	Stigma Intervention Group n = 87
30 days after intervention	77	77
90 days after intervention	79	76
180 days after intervention	76	76

Population analysed: Analysis includes participants who completed the visit at the applicable time point.

Primary outcome: Percent of Questions Left Blank on Study Instruments

Time frame: baseline and 30, 90, and 180 days after intervention. Number. Unit: percent of questions left blank

Measure	Treatment as Usual Group n = 80	Stigma Intervention Group n = 87
baseline	0	0
30 days after intervention	0	0
90 days after intervention	0	0
180 days after intervention	0	0

Population analysed: Analysis includes participants who completed surveys at the time point indicated.

Primary outcome: Time it Takes in Minutes for Participants to Complete the Questionnaires

Time frame: baseline and 30, 90, and 180 days after intervention. Mean (Standard Deviation). Unit: minutes

Measure	Treatment as Usual Group n = 80	Stigma Intervention Group n = 87
Baseline	48 (8)	49 (8)
30 days	42 (11)	41 (9)
90 days	44 (9)	42 (8)
180 days	43 (5)	43 (7)

Population analysed: Analysis includes participants who completed surveys at the time point indicated.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: baseline and 30, 90, and 180 days after intervention. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment as Usual Group	0 of 80 (0%)	0 of 80 (0%)	0 of 80
Stigma Intervention Group	0 of 87 (0%)	0 of 87 (0%)	0 of 87

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40138392Nyblade L, Kilonzo MN, Kisamo DH, Mtei RJ, Pan W, Relf MV. Efficacy Testing of a Culturally Relevant Stigma Reduction Intervention for Women Living With HIV in Tanzania: Protocol for a Randomized Controlled Trial. J Assoc Nurses AIDS Care. 2025 Mar 26;36(5):470-481. doi: 10.1097/JNC.0000000000000538.
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.

Michael V. Relf, PhD principal investigator

Duke University School of Nursing

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Labda Siku Moja stigma reduction intervention in people with HIV and Stigma, Social, run by Duke 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 8 inclusion and 3 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 29 May 2025. 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?

Yes. Results are posted in the registry (first posted 29 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Participants Recruited as Measured by Enrollment Logs (time frame: up to 6 months). The study lists 5 primary outcomes in all. 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 NCT05033002, 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 29 May 2025.