Trial Outcomes & Findings for A Stigma Reduction Intervention at Time of Entry Into Antenatal Care to Improve PMTCT Services in Tanzania (NCT NCT03600142)
NCT ID: NCT03600142
Last Updated: 2022-03-10
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1539 participants
Primary outcome timeframe
Post-assessment (3 months after enrollment)
Results posted on
2022-03-10
Participant Flow
Participant milestones
| Measure |
Standard of Care (SoC)
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.
|
SoC + Stigma Counseling (Maisha)
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.
|
|---|---|---|
|
Overall Study
STARTED
|
777
|
762
|
|
Overall Study
COMPLETED
|
773
|
758
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Stigma Reduction Intervention at Time of Entry Into Antenatal Care to Improve PMTCT Services in Tanzania
Baseline characteristics by cohort
| Measure |
Standard of Care (SoC)
n=773 Participants
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)
n=758 Participants
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
n=1531 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
26 years
n=93 Participants
|
26 years
n=4 Participants
|
26 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
519 Participants
n=93 Participants
|
520 Participants
n=4 Participants
|
1039 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
254 Participants
n=93 Participants
|
238 Participants
n=4 Participants
|
492 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
773 Participants
n=93 Participants
|
758 Participants
n=4 Participants
|
1531 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
Tanzania
|
773 participants
n=93 Participants
|
758 participants
n=4 Participants
|
1531 participants
n=27 Participants
|
|
Had Secondary Education
|
319 Participants
n=93 Participants
|
316 Participants
n=4 Participants
|
635 Participants
n=27 Participants
|
|
Married
|
484 Participants
n=93 Participants
|
458 Participants
n=4 Participants
|
942 Participants
n=27 Participants
|
|
Employed
|
141 Participants
n=93 Participants
|
161 Participants
n=4 Participants
|
302 Participants
n=27 Participants
|
|
HIV Positive
|
31 Participants
n=93 Participants
|
35 Participants
n=4 Participants
|
66 Participants
n=27 Participants
|
|
Stigmatizing Attitudes
|
10 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
|
Anticipated Stigma
|
7 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Standard of Care (SoC)
n=26 Participants
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)
n=28 Participants
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.
|
|---|---|---|
|
HIV Care Engagement (Female HIV-infected Participants Only)
|
3 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Standard of Care (SoC)
n=134 Participants
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)
n=159 Participants
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.
|
|---|---|---|
|
Attitudes Toward People Living With HIV, Blame/Judgement Subscale (HIV-uninfected Participants Only)
|
6.4 units on a scale
Standard Deviation 4.6
|
4.6 units on a scale
Standard Deviation 4.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
Outcome measures
Outcome data not reported
Adverse Events
Standard of Care (SoC)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
SoC + Stigma Counseling (Maisha)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place