N/A
N=167
Efficacy Testing of a Culturally Relevant Stigma Intervention With WLWH in Tanzania
HIV · Stigma, Social · Self Efficacy · Self Esteem · Hope
Bottom Line
View on ClinicalTrials.gov: NCT05033002 ↗Enrolled (actual)
167
Serious AEs
0.0%
Results posted
May 2025
Primary outcome: Primary: Number of Participants Recruited as Measured by Enrollment Logs — 80; 87 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Labda Siku Moja stigma reduction intervention (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Duke University
- Primary completion
- May 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Recruited as Measured by Enrollment Logs |
80; 87 | — |
| PRIMARY Number of Study Participants Retained in Study as Measured by Enrollment Logs |
77; 77; 79; 76; 76; 76 | — |
| PRIMARY Percent of Questions Left Blank on Study Instruments |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Time it Takes in Minutes for Participants to Complete the Questionnaires |
48; 49; 42; 41; 44; 42 | — |
| PRIMARY Number of Women Who Completed All 5 Sessions |
76 | — |
| SECONDARY Change in Internalized Stigma, as Measured by the Swahili Version of the Multidimensional Measure of Internalized Stigma Scale |
36.72; 40.18; 24.89; 6.01; 23.58; 5.21 | <.0001 sig |
| SECONDARY Change in Coping Self-efficacy, as Measured by the Swahili Version of the Coping Self-Efficacy Scale |
13.28; 13.17; 14.4; 17.86; 14.9; 18.00 | .002 sig |
| SECONDARY Change in Self-esteem, as Measured by the Swahili Version of the Rosenberg Self-Esteem Scale |
28.30; 28.17; 29.97; 32.66; 29.57; 32.26 | .001 sig |
| SECONDARY Hope, as Measured by the Swahili Version of the State of Hope Scale |
15.48; 15.82 | 0.506 |
| SECONDARY Change in Depressive Symptoms, as Measured by the Swahili Version of the Patient Health Questionnaire 9 |
4.20; 4.63; 3.05; 2.09; 2.00; 1.77 | .441 |
Summary
This study will test a stigma reduction intervention with women living with HIV in Tanzania.
Eligibility Criteria
Inclusion Criteria
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.
Exclusion Criteria
- (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
Data sourced from ClinicalTrials.gov (NCT05033002). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.