HIV InfectionsMaishaNCT03600142
A Stigma Reduction Intervention at Time of Entry Into Antenatal Care to Improve PMTCT Services in Tanzania
A study testing Mashia in people with HIV Infections, run by University of Utah at 1 site in Tanzania.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Mashia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,539 participants
- Where
- 1 siteTanzania
- Study dates
- 8 Apr 2019to 15 Mar 2020
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Impaired mental status
- Does not speak Swahili
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Stigma Reduction Intervention at Time of Entry Into Antenatal Care to Improve PMTCT Services in Tanzania (Maisha)
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.
Read the 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.
- Conditions
- HIV Infections
- Being tested
- Mashia
- Keywords
- Stigma, HIV, Counseling, Tanzania, Pregnancy, Cognitive-behavioral therapy, Retention in care, Prevention of mother to child transmission
- Medical subject headings
- HIV Infections, Social Stigma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MashiaBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care (SoC) | No intervention | 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. |
| SoC + stigma counseling (Maisha) | Experimental | 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. Receives: Behavioral: Mashia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Post-assessment (3 months after enrollment)
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.
Measured: Post-assessment (3 months after enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start8 Apr 2019
- Primary completion15 Mar 2020
- Study completion15 Mar 2020
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 (4)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,539 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Kilimanjaro Christian Medical Centre, Tanzania, Fogarty International Center of the National Institute of Health
- Responsible party
- Principal investigator, Melissa Watt, University of Utah
- Investigators
- Melissa Watt, PhD, Principal investigator, University of UtahBlandina Mmbaga, MD, PhD, Principal investigator, Kilimanjaro Christian Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03600142
- Sponsor's protocol ID
- 1R21TW011053-01
- Other IDs
- 1R21TW011053-01
- Acronym
- Maisha
- Status last verified
- Jun 2026
- First submitted
- 16 Jul 2018
- Last updated
- 6 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data from the formative and pilot trial work in this R21 will be shared within the constraints required for the protection of confidentiality for study subjects. With a data transfer agreement from our Institutional Review Board, the investigators are willing to share raw data with researchers and program leaders from other institutions.
Publications
Watt MH, Knettel BA, Knippler ET, Kisigo G, Ngocho JS, Renju J, Rogathi J, Sao SS, Minja L, Osaki H, Mwamba RN, Mmbaga BT. The development of Maisha, a video-assisted counseling intervention to address HIV stigma at entry into antenatal care in Tanzania. Eval Program Plann. 2020 Dec;83:101859. doi: 10.1016/j.evalprogplan.2020.101859. Epub 2020 Aug 5.
PubMed 32795711Watt MH, Minja L, Knettel BA, Mwamba RN, Osaki H, Ngocho JS, Kisigo GA, Renju J, Vissoci JRN, Sao SS, Mmbaga BT. Pilot Outcomes of Maisha: An HIV Stigma Reduction Intervention Developed for Antenatal Care in Tanzania. AIDS Behav. 2021 Apr;25(4):1171-1184. doi: 10.1007/s10461-020-03093-9. Epub 2020 Nov 12.
PubMed 33180253Cohen SR, Marchand V, Calkins K, Stephens MJ, Barabara ML, Minja LM, Olomi GA, Mlay J, Mlay PS, Hanson OR, Mmbaga BT, Watt MH. Participatory simulation training design: The MAMA interprofessional team-training program for obstetric care of pregnant individuals living with HIV in Tanzania. Eval Program Plann. 2025 Jun;110:102550. doi: 10.1016/j.evalprogplan.2025.102550. Epub 2025 Jan 31.
PubMed 39914273Watt MH, Knippler ET, Minja L, Kisigo G, Knettel BA, Ngocho JS, Renju J, Osaki H, Mwamba R, Rogathi JJ, Mmbaga BT. A counseling intervention to address HIV stigma at entry into antenatal care in Tanzania (Maisha): study protocol for a pilot randomized controlled trial. Trials. 2019 Dec 30;20(1):807. doi: 10.1186/s13063-019-3933-z.
PubMed 31888700
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Stigma Reduction Intervention at Time of Entry Into Antenatal Care to Improve PMTCT Services in Tanzania (Maisha)
- ClinicalTrials.gov ID
- NCT03600142
- Acronym / sponsor ID
- Maisha / 1R21TW011053-01
- Conditions
- HIV Infections
- Keywords
- Stigma, HIV, Counseling, Tanzania, Pregnancy, Cognitive-behavioral therapy, Retention in care, Prevention of mother to child transmission
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,539 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Kilimanjaro Christian Medical Centre, Tanzania, Fogarty International Center of the National Institute of Health
- Study start
- 8 Apr 2019 (actual)
- Primary completion
- 15 Mar 2020 (actual)
- Study completion
- 15 Mar 2020 (actual)
- First posted
- 26 Jul 2018 (actual)
- Results
- Posted 20 Sep 2021
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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care (SoC) | No intervention | –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. |
| SoC + stigma counseling (Maisha) | Experimental | Behavioral: MashiaParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Impaired mental status
- Does not speak Swahili
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 |
|---|---|---|
| MashiaMaisha 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. | Behavioural | SoC + stigma counseling (Maisha) |
Primary outcome
HIV Care Engagement (Female HIV-infected Participants Only)
Time frame: 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)
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 32795711Watt MH, Knettel BA, Knippler ET, Kisigo G, Ngocho JS, Renju J, Rogathi J, Sao SS, Minja L, Osaki H, Mwamba RN, Mmbaga BT. The development of Maisha, a video-assisted counseling intervention to address HIV stigma at entry into antenatal care in Tanzania. Eval Program Plann. 2020 Dec;83:101859. doi: 10.1016/j.evalprogplan.2020.101859. Epub 2020 Aug 5.
- Results publication: PubMed 33180253Watt MH, Minja L, Knettel BA, Mwamba RN, Osaki H, Ngocho JS, Kisigo GA, Renju J, Vissoci JRN, Sao SS, Mmbaga BT. Pilot Outcomes of Maisha: An HIV Stigma Reduction Intervention Developed for Antenatal Care in Tanzania. AIDS Behav. 2021 Apr;25(4):1171-1184. doi: 10.1007/s10461-020-03093-9. Epub 2020 Nov 12.
- Derived from this study: PubMed 39914273Cohen SR, Marchand V, Calkins K, Stephens MJ, Barabara ML, Minja LM, Olomi GA, Mlay J, Mlay PS, Hanson OR, Mmbaga BT, Watt MH. Participatory simulation training design: The MAMA interprofessional team-training program for obstetric care of pregnant individuals living with HIV in Tanzania. Eval Program Plann. 2025 Jun;110:102550. doi: 10.1016/j.evalprogplan.2025.102550. Epub 2025 Jan 31.
- Derived from this study: PubMed 31888700Watt MH, Knippler ET, Minja L, Kisigo G, Knettel BA, Ngocho JS, Renju J, Osaki H, Mwamba R, Rogathi JJ, Mmbaga BT. A counseling intervention to address HIV stigma at entry into antenatal care in Tanzania (Maisha): study protocol for a pilot randomized controlled trial. Trials. 2019 Dec 30;20(1):807. doi: 10.1186/s13063-019-3933-z.
- Individual participant dataSharing planned: Yes. The data from the formative and pilot trial work in this R21 will be shared within the constraints required for the protection of confidentiality for study subjects. With a data transfer agreement from our Institutional Review Board, the investigators are willing to share raw data with researchers and program leaders from other institutions.
Related trials for HIV Infections
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
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.
Melissa Watt, PhD principal investigator
University of Utah
Blandina Mmbaga, MD, PhD principal investigator
Kilimanjaro Christian Medical Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mashia in people with HIV Infections, run by University of Utah 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 3 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 6 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 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 20 Sep 2021). 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?
HIV Care Engagement (Female HIV-infected Participants Only) (time frame: Post-assessment (3 months after enrollment)). The study lists 2 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 NCT03600142, which also lists 4 linked publications.
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 6 Jul 2026.