Maisha: A Stigma Reduction Intervention at Time of Entry Into Antenatal Care to Improve PMTCT Services in Tanzania
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: 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. |
|
| Experimental: 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. |
Behavioral: 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.
|
Outcome Measures
Primary Outcome Measures
- 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.
Other Outcome Measures
- Quality Assurance (QA Data) [Post-assessment (3 months after enrollment)]
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.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kilimanjaro Christian Medical Centre | Moshi | Tanzania |
Sponsors and Collaborators
- University of Utah
- Kilimanjaro Christian Medical Centre, Tanzania
- Fogarty International Center of the National Institute of Health
Investigators
- Principal Investigator: Melissa Watt, PhD, University of Utah
- Principal Investigator: Blandina Mmbaga, MD, PhD, Kilimanjaro Christian Medical Centre
Study Documents (Full-Text)
More Information
Publications
- 1R21TW011053-01
- 1R21TW011053-01
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Standard of Care (SoC) | SoC + Stigma Counseling (Maisha) |
|---|---|---|
| Arm/Group Description | Participants randomized to the control condition (n=773) received the standard HIV counseling protocol in the clinic, which was 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 tested positive for HIV, counseling helped the woman/couple to accept an HIV test result and discuss implications for treatment. | Participants randomized to the intervention condition (n=758) received 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 tested positive for HIV, two counseling sessions. If a male partner was present with the women, he was also enrolled and participated 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 was 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. |
| Period Title: Overall Study | ||
| STARTED | 777 | 762 |
| COMPLETED | 773 | 758 |
| NOT COMPLETED | 4 | 4 |
Baseline Characteristics
| Arm/Group Title | Standard of Care (SoC) | SoC + Stigma Counseling (Maisha) | Total |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | Total of all reporting groups |
| Overall Participants | 773 | 758 | 1531 |
| Age (years) [Mean (Inter-Quartile Range) ] | |||
| Mean (Inter-Quartile Range) [years] |
26
|
26
|
26
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
519
67.1%
|
520
68.6%
|
1039
67.9%
|
| Male |
254
32.9%
|
238
31.4%
|
492
32.1%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
773
100%
|
758
100%
|
1531
100%
|
| White |
0
0%
|
0
0%
|
0
0%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (participants) [Number] | |||
| Tanzania |
773
100%
|
758
100%
|
1531
100%
|
| Had Secondary Education (Count of Participants) | |||
| Count of Participants [Participants] |
319
41.3%
|
316
41.7%
|
635
41.5%
|
| Married (Count of Participants) | |||
| Count of Participants [Participants] |
484
62.6%
|
458
60.4%
|
942
61.5%
|
| Employed (Count of Participants) | |||
| Count of Participants [Participants] |
141
18.2%
|
161
21.2%
|
302
19.7%
|
| HIV Positive (Count of Participants) | |||
| Count of Participants [Participants] |
31
4%
|
35
4.6%
|
66
4.3%
|
| Stigmatizing Attitudes (Count of Participants) | |||
| Count of Participants [Participants] |
10
1.3%
|
12
1.6%
|
22
1.4%
|
| Anticipated Stigma (Count of Participants) | |||
| Count of Participants [Participants] |
7
0.9%
|
8
1.1%
|
15
1%
|
Outcome Measures
| Title | HIV Care Engagement (Female HIV-infected Participants Only) |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Standard of Care (SoC) | SoC + Stigma Counseling (Maisha) |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 26 | 28 |
| Count of Participants [Participants] |
3
0.4%
|
3
0.4%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Standard of Care (SoC), SoC + Stigma Counseling (Maisha) |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Non-Inferiority | |
| Comments | For WLHIV (n=55), chi-square tests were used to assess differences between conditions in the proportion of participants who were retained in HIV care at 3 months post enrollment. | |
| Statistical Test of Hypothesis | p-Value | 0.963 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
| Title | Attitudes Toward People Living With HIV, Blame/Judgement Subscale (HIV-uninfected Participants Only) |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Standard of Care (SoC) | SoC + Stigma Counseling (Maisha) |
|---|---|---|
| Arm/Group Description | Participants randomized to the control condition (n=773) received the standard HIV counseling protocol in the clinic, which was 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 tested positive for HIV, counseling helped the woman/couple to accept an HIV test result and discuss implications for treatment. | Participants randomized to the intervention condition (n=758) received 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 tested positive for HIV, two counseling sessions. If a male partner was present with the women, he was also enrolled and participated 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 was 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. |
| Measure Participants | 134 | 159 |
| Mean (Standard Deviation) [units on a scale] |
6.4
(4.6)
|
4.6
(4.0)
|
| Title | Quality Assurance (QA Data) |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
Adverse Events
| Time Frame | Through study completion, an average of 3 months. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | The definition of adverse events and/or serious adverse events does not differ from the ClinicalTrials.gov definition. | |||
| Arm/Group Title | Standard of Care (SoC) | SoC + Stigma Counseling (Maisha) | ||
| Arm/Group Description | Participants randomized to the control condition (n=773) received the standard HIV counseling protocol in the clinic, which was 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 tested positive for HIV, counseling helped the woman/couple to accept an HIV test result and discuss implications for treatment. | Participants randomized to the intervention condition (n=758) received 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 tested positive for HIV, two counseling sessions. If a male partner was present with the women, he was also enrolled and participated 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 was 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. | ||
All Cause Mortality |
||||
| Standard of Care (SoC) | SoC + Stigma Counseling (Maisha) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/777 (0%) | 0/762 (0%) | ||
Serious Adverse Events |
||||
| Standard of Care (SoC) | SoC + Stigma Counseling (Maisha) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/777 (0%) | 0/762 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Standard of Care (SoC) | SoC + Stigma Counseling (Maisha) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/777 (0%) | 0/762 (0%) | ||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Melissa Watt |
|---|---|
| Organization | University of Utah |
| Phone | 8015817201 |
| melissa.watt@hsc.utah.edu |
- 1R21TW011053-01
- 1R21TW011053-01