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A Stigma Reduction Intervention at Time of Entry Into Antenatal Care to Improve PMTCT Services in Tanzania

A Stigma Reduction Intervention at Time of Entry Into Antenatal Care to Improve PMTCT Services in Tanzania (Maisha)

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03600142
Acronym
Maisha
Enrollment
1539
Registered
2018-07-26
Start date
2019-04-08
Completion date
2020-03-15
Last updated
2026-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

Stigma, HIV, Counseling, Tanzania, Pregnancy, Cognitive-behavioral therapy, Retention in care, Prevention of mother to child transmission

Brief summary

This study will pilot test a brief, scalable intervention called Maisha (Swahili for life), to address HIV stigma for women presenting to antenatal care in Tanzania and male partners who accompany them. The intervention will include: 1) a video and brief counseling that addresses HIV stigma at the start of the ANC visit (prior to HIV testing), and 2) two stigma-based counseling sessions for individuals who are HIV infected, building on the video content to provide emotional support, promote acceptance, address stigma, and reinforce care engagement. The primary intervention outcome is engagement in PMTCT care among women who are HIV infected. The investigators will also examine HIV stigma outcomes (enacted, anticipated, internalized) among all groups of participants, including individuals who are already established on ART and indiviudals who are HIV uninfected.

Detailed description

HIV-related stigma has been identified as a significant reason for loss to follow up in prevention of mother-to-child transmission of HIV (PMTCT) programs. Antenatal care (ANC) provides a unique and important entry point to address HIV stigma. Stigma-based counseling during the first ANC visit can promote readiness to initiate or sustain treatment among those who are HIV infected, and can address stigmatizing attitudes and behaviors among those who are uninfected. We are proposing to pilot test a brief, scalable intervention called Maisha (Swahili for life), to address HIV stigma for women and their partners presenting to ANC in Tanzania. The intervention will include: 1) a video and brief counseling for women and their partners (if present) that addresses HIV stigma at the start of the ANC visit (prior to HIV testing), and 2) two stigma-based counseling sessions for women who are HIV infected, building on the video content to provide emotional support, promote acceptance, address stigma, and reinforce care engagement, with the opportunity for male partners to attend the first follow-up counseling session after testing. The primary intervention outcome is engagement in PMTCT care among women who are HIV infected. As a secondary outcome we will also look at linkage to HIV care among men who are HIV infected. We will also examine HIV stigma outcomes (enacted, anticipated, internalized) among all groups of people, including those who are already established on ART and those who are HIV uninfected. The intervention content is based on principles of cognitive-behavioral therapy (addressing automatic negative thoughts about the self, future and the world) to address and mitigate multiple forms of HIV stigma (internalized, anticipated and enacted). We will conduct a pilot RCT of the intervention, enrolling all women who attend a first ANC appointment at two clinics in the Moshi district. If women come to the ANC visit with a male partner, the partner will be invited to enroll as well. Maisha will be compared to the standard of care HIV counseling. In addition to a baseline assessment, all participants who are identified as HIV-infected and their partners will get a follow-up assessment three months after enrollment. A subset of participants who are identified as HIV-uninfected but who report high levels of HIV stigmatizing attitudes at baseline will also receive a follow-up assessment three months after enrollment. Measures will include health outcomes (care engagement, adherence, depression), stigma outcomes, and HIV disclosure. Quality assurance data will be collected and the feasibility and acceptability of the intervention and RCT will be described. Statistical analysis will examine differences between conditions in health outcomes and stigma measures, stratified by HIV status. We hypothesize that 1) among HIV infected individuals, individuals receiving the Maisha intervention will report better engagement in PMTCT care/linkage to HIV care and lower levels of internalized HIV stigma, as compared to individuals receiving the standard of care, and 2) among HIV uninfected individuals, individuals receiving the pre-test video and counseling will report lower levels of stigmatizing attitudes when compared with the control group.

Interventions

BEHAVIORALMashia

Maisha is a brief, scalable, theory-based counseling intervention that addresses HIV stigma at entry into antenatal care. The intervention will be developed in a formative phase and includes 1) a video and counseling session prior to HIV testing that addresses HIV stigma, and 2) two post-test HIV counseling sessions for HIV-infected individuals, building on the video content to provide emotional support, address stigma, and reinforce the value of care engagement.

Sponsors

University of Utah
Lead SponsorOTHER
Kilimanjaro Christian Medical Centre, Tanzania
CollaboratorOTHER
Fogarty International Center of the National Institute of Health
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 18 years of age or older * If female: Pregnant and attending first antenatal care (ANC) appointment for the current pregnancy at one of the two study sites * If male: Accompanying an enrolled woman to her first ANC appointment.

Exclusion criteria

* Impaired mental status * Does not speak Swahili

Design outcomes

Primary

MeasureTime frameDescription
HIV Care Engagement (Female HIV-infected Participants Only)Post-assessment (3 months after enrollment)For HIV-infected female participants, retention in care will be assessed via medical record review, with retention defined as having no more than a 60 day gap between PMTCT visits at the study clinic, or having record of an official transfer to another clinic.
Attitudes Toward People Living With HIV, Blame/Judgement Subscale (HIV-uninfected Participants Only)Post-assessment (3 months after enrollment)Self-report, measured by a modified version of personal and attributed stigma scales (Visser, Kershaw, Makin, \& Forsyth, 2008) Scoring: 6 items. Item scores range from 0-3 (Strongly Disagree to Strongly Agree). Item responses are totaled for a summary score. Total scores range 0-18, with higher scores indicating greater stigma.

Countries

Tanzania

Contacts

PRINCIPAL_INVESTIGATORMelissa Watt, PhD

University of Utah

PRINCIPAL_INVESTIGATORBlandina Mmbaga, MD, PhD

Kilimanjaro Christian Medical Centre

Participant flow

Participants by arm

ArmCount
Standard of Care (SoC)
Participants randomized to the control condition will receive the standard HIV counseling protocol in the clinic, which is administered by clinic nurses. According to the Tanzania PMTCT guidelines, HIV pre-test counseling should provide education about HIV and prepare a woman (and her partner, if present) for HIV testing. For anyone who tests positive for HIV, counseling should help the woman/couple to accept an HIV test result and discuss implications for treatment.
773
SoC + Stigma Counseling (Maisha)
Participants randomized to the intervention condition will receive the SoC counseling plus Maisha, a brief, scalable, theory-based counseling intervention that addresses HIV stigma at entry into antenatal care. Maisha involves a video delivered to all women prior to HIV testing, and, if a woman tests positive for HIV, two counseling sessions. If a male partner is present with the women, he may also be enrolled and participate in the first two counseling sessions together with the woman. Mashia: Maisha is a brief, scalable, theory-based counseling intervention that addresses HIV stigma at entry into antenatal care. The intervention will be developed in a formative phase and includes 1) a video and counseling session prior to HIV testing that addresses HIV stigma, and 2) two post-test HIV counseling sessions for HIV-infected individuals, building on the video content to provide emotional support, address stigma, and reinforce the value of care engagement.
758
Total1,531

Baseline characteristics

CharacteristicStandard of Care (SoC)TotalSoC + Stigma Counseling (Maisha)
Age, Continuous26 years26 years26 years
Anticipated Stigma7 Participants15 Participants8 Participants
Employed141 Participants302 Participants161 Participants
Had Secondary Education319 Participants635 Participants316 Participants
HIV Positive31 Participants66 Participants35 Participants
Married484 Participants942 Participants458 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
773 Participants1531 Participants758 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
0 Participants0 Participants0 Participants
Region of Enrollment
Tanzania
773 participants1531 participants758 participants
Sex: Female, Male
Female
519 Participants1039 Participants520 Participants
Sex: Female, Male
Male
254 Participants492 Participants238 Participants
Stigmatizing Attitudes10 Participants22 Participants12 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 7770 / 762
other
Total, other adverse events
0 / 7770 / 762
serious
Total, serious adverse events
0 / 7770 / 762

Outcome results

Primary

Attitudes Toward People Living With HIV, Blame/Judgement Subscale (HIV-uninfected Participants Only)

Self-report, measured by a modified version of personal and attributed stigma scales (Visser, Kershaw, Makin, & Forsyth, 2008) Scoring: 6 items. Item scores range from 0-3 (Strongly Disagree to Strongly Agree). Item responses are totaled for a summary score. Total scores range 0-18, with higher scores indicating greater stigma.

Time frame: Post-assessment (3 months after enrollment)

Population: A sub-set up individuals who were HIV-negative at baseline were invited to return for 3-month follow-up. Individuals with total stigmatizing attitude scores \>14 were eligible for follow-up; of those who met criteria, a random 60% were invited for follow-up in order to reach a minimum sample powered to detect differences in HIV stigma.

ArmMeasureValue (MEAN)Dispersion
Standard of Care (SoC)Attitudes Toward People Living With HIV, Blame/Judgement Subscale (HIV-uninfected Participants Only)6.4 units on a scaleStandard Deviation 4.6
SoC + Stigma Counseling (Maisha)Attitudes Toward People Living With HIV, Blame/Judgement Subscale (HIV-uninfected Participants Only)4.6 units on a scaleStandard Deviation 4
Primary

HIV Care Engagement (Female HIV-infected Participants Only)

For HIV-infected female participants, retention in care will be assessed via medical record review, with retention defined as having no more than a 60 day gap between PMTCT visits at the study clinic, or having record of an official transfer to another clinic.

Time frame: Post-assessment (3 months after enrollment)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Standard of Care (SoC)HIV Care Engagement (Female HIV-infected Participants Only)3 Participants
SoC + Stigma Counseling (Maisha)HIV Care Engagement (Female HIV-infected Participants Only)3 Participants
Comparison: We were aware that our resources of time and funding would not be sufficient to detect a significant difference in the HIV care outcome, and that we would only be able to detect observational signals of impact. We aimed for a minimum of 50 WLHIV, which is considered an adequate sample to assess feasibility and acceptability in a pilot intervention study. Given an estimated 5% HIV prevalence among women presenting for ANC, this required us to enroll 1000 female participants.p-value: 0.963Chi-squared
Other Pre-specified

Quality Assurance (QA Data)

Quality assurance data will be collected on feasibility, acceptability, and fidelity of Maisha session to the intervention manual. Sessions will be recorded and a subset of recordings will be reviewed to assess whether core components of the sessions were completed. Follow-up surveys will include items on participant satisfaction with the intervention format, session content, and interventionist. A subset of participants will also be selected to give additional qualitative feedback.

Time frame: Post-assessment (3 months after enrollment)

Source: ClinicalTrials.gov · Data processed: Jul 7, 2026