Trial Outcomes & Findings for Reducing Intersectional Stigma Among High-Risk Women in Brazil to Promote Uptake of HIV Testing and PrEP (NCT NCT04114955)
NCT ID: NCT04114955
Last Updated: 2026-02-25
Results Overview
Self- and clinic-based HIV testing
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
392 participants
Primary outcome timeframe
Every 3 months through study completion, up to 12 months
Results posted on
2026-02-25
Participant Flow
Participants assessed for eligibility (n=653) Ineligible (n=60): Living outside São Paulo (35); Less than 18 years of age (1); HIV+ (24) Declined (n=69): Too busy (n=33); Not interested (n=23); Objected to study protocol (n=8); Not emotionally stable (n=1); Moving from the city (n=4) Never scheduled or missed enrollment visit: 132
392 Randomized on day of enrollment
Participant milestones
| Measure |
Immediate Intervention
Group to receive Manas Intervention (group and individual peer navigation) in Year 1 of the study
|
Delayed Intervention
Group to receive Manas Intervention (group and individual peer navigation) in Year 2 of the study
|
|---|---|---|
|
Overall Study
STARTED
|
198
|
194
|
|
Overall Study
COMPLETED
|
179
|
178
|
|
Overall Study
NOT COMPLETED
|
19
|
16
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Reducing Intersectional Stigma Among High-Risk Women in Brazil to Promote Uptake of HIV Testing and PrEP
Baseline characteristics by cohort
| Measure |
Immediate Intervention
n=198 Participants
Group to receive Manas Intervention (group and individual peer navigation) in Year 1 of the study
|
Delayed Intervention
n=194 Participants
Group to receive Manas Intervention (group and individual peer navigation) in Year 2 of the study
|
Total
n=392 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age · 18-29 years
|
75 Participants
n=24 Participants
|
90 Participants
n=20 Participants
|
165 Participants
n=40 Participants
|
|
Age, Customized
Age · 30-39 years
|
72 Participants
n=24 Participants
|
52 Participants
n=20 Participants
|
124 Participants
n=40 Participants
|
|
Age, Customized
Age · 40-49 years
|
38 Participants
n=24 Participants
|
44 Participants
n=20 Participants
|
82 Participants
n=40 Participants
|
|
Age, Customized
Age · 50 years and over
|
13 Participants
n=24 Participants
|
8 Participants
n=20 Participants
|
21 Participants
n=40 Participants
|
|
Sex: Female, Male
Female
|
198 Participants
n=24 Participants
|
194 Participants
n=20 Participants
|
392 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Race · Black
|
52 Participants
n=24 Participants
|
47 Participants
n=20 Participants
|
99 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
52 Participants
n=24 Participants
|
55 Participants
n=20 Participants
|
107 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Race · More than 1 race
|
87 Participants
n=24 Participants
|
91 Participants
n=20 Participants
|
178 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Race · Indigenous, Asian, or Other
|
7 Participants
n=24 Participants
|
1 Participants
n=20 Participants
|
8 Participants
n=40 Participants
|
|
Marital status
Single
|
142 Participants
n=24 Participants
|
147 Participants
n=20 Participants
|
289 Participants
n=40 Participants
|
|
Marital status
In a relationship
|
28 Participants
n=24 Participants
|
14 Participants
n=20 Participants
|
42 Participants
n=40 Participants
|
|
Marital status
Married or living with partner
|
28 Participants
n=24 Participants
|
33 Participants
n=20 Participants
|
61 Participants
n=40 Participants
|
|
Education
Primary or less
|
31 Participants
n=24 Participants
|
31 Participants
n=20 Participants
|
62 Participants
n=40 Participants
|
|
Education
Incomplete secondary
|
49 Participants
n=24 Participants
|
47 Participants
n=20 Participants
|
96 Participants
n=40 Participants
|
|
Education
Secondary or more
|
118 Participants
n=24 Participants
|
116 Participants
n=20 Participants
|
234 Participants
n=40 Participants
|
|
Sex work past 30 days
No
|
122 Participants
n=24 Participants
|
121 Participants
n=20 Participants
|
243 Participants
n=40 Participants
|
|
Sex work past 30 days
Yes
|
76 Participants
n=24 Participants
|
73 Participants
n=20 Participants
|
149 Participants
n=40 Participants
|
|
Housing status
Stable housing
|
146 Participants
n=24 Participants
|
142 Participants
n=20 Participants
|
288 Participants
n=40 Participants
|
|
Housing status
Unstable housing
|
52 Participants
n=24 Participants
|
52 Participants
n=20 Participants
|
104 Participants
n=40 Participants
|
|
HIV test in prior 12 months
No
|
49 Participants
n=24 Participants
|
57 Participants
n=20 Participants
|
106 Participants
n=40 Participants
|
|
HIV test in prior 12 months
Yes
|
149 Participants
n=24 Participants
|
137 Participants
n=20 Participants
|
286 Participants
n=40 Participants
|
|
Prior use of PrEP
No
|
145 Participants
n=24 Participants
|
135 Participants
n=20 Participants
|
280 Participants
n=40 Participants
|
|
Prior use of PrEP
Yes
|
53 Participants
n=24 Participants
|
59 Participants
n=20 Participants
|
112 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: Every 3 months through study completion, up to 12 monthsPopulation: 1 participant died prior to accruing any follow up data. Most participants contributed 4 intervals; participants newly diagnosed with HIV and participants who passed away during the study contributed fewer.
Self- and clinic-based HIV testing
Outcome measures
| Measure |
Immediate Intervention
n=197 Participants
Group to receive Manas Intervention (group and individual peer navigation) in Year 1 of the study
|
Delayed Intervention
n=194 Participants
Group to receive Manas Intervention (group and individual peer navigation) in Year 2 of the study
|
|---|---|---|
|
Changes in HIV Testing
Interval 3: 6-9 months · Not tested
|
94 Participants
|
84 Participants
|
|
Changes in HIV Testing
Interval 3: 6-9 months · Missing
|
14 Participants
|
18 Participants
|
|
Changes in HIV Testing
Interval 4: 9-12 months · Tested
|
100 Participants
|
102 Participants
|
|
Changes in HIV Testing
Interval 4: 9-12 months · Not tested
|
71 Participants
|
70 Participants
|
|
Changes in HIV Testing
Interval 4: 9-12 months · Missing
|
25 Participants
|
18 Participants
|
|
Changes in HIV Testing
Interval 1: 0-3 months · Tested
|
102 Participants
|
100 Participants
|
|
Changes in HIV Testing
Interval 1: 0-3 months · Not tested
|
87 Participants
|
83 Participants
|
|
Changes in HIV Testing
Interval 1: 0-3 months · Missing
|
8 Participants
|
11 Participants
|
|
Changes in HIV Testing
Interval 2: 3-6 months · Tested
|
102 Participants
|
105 Participants
|
|
Changes in HIV Testing
Interval 2: 3-6 months · Not tested
|
74 Participants
|
68 Participants
|
|
Changes in HIV Testing
Interval 2: 3-6 months · Missing
|
21 Participants
|
19 Participants
|
|
Changes in HIV Testing
Interval 3: 6-9 months · Tested
|
88 Participants
|
88 Participants
|
PRIMARY outcome
Timeframe: Every 3 months through study completion, up to 12 monthsPopulation: Ineligible individuals include: * Individuals with active PrEP prescription 30 days prior to enrollment or up to 7 days after enrollment (N=77) * Individuals deceased in the first interval before any follow-up data collected (N=1) * Individuals enrolling in other research studies related to PrEP products (N=6) Participant intervals are censored after PrEP initiation or on loss to follow up, as tabulated below.
Initiation of pre-exposure prophylaxis, measured as first filled PrEP prescription
Outcome measures
| Measure |
Immediate Intervention
n=160 Participants
Group to receive Manas Intervention (group and individual peer navigation) in Year 1 of the study
|
Delayed Intervention
n=148 Participants
Group to receive Manas Intervention (group and individual peer navigation) in Year 2 of the study
|
|---|---|---|
|
Changes in PrEP Uptake
Interval 1: 0-3 months · Initiated PrEP
|
10 Participants
|
5 Participants
|
|
Changes in PrEP Uptake
Interval 1: 0-3 months · Did not initiate PrEP
|
150 Participants
|
143 Participants
|
|
Changes in PrEP Uptake
Interval 1: 0-3 months · Lost to follow up
|
0 Participants
|
0 Participants
|
|
Changes in PrEP Uptake
Interval 2: 3-6 months · Initiated PrEP
|
14 Participants
|
12 Participants
|
|
Changes in PrEP Uptake
Interval 2: 3-6 months · Did not initiate PrEP
|
136 Participants
|
129 Participants
|
|
Changes in PrEP Uptake
Interval 2: 3-6 months · Lost to follow up
|
0 Participants
|
2 Participants
|
|
Changes in PrEP Uptake
Interval 3: 6-9 months · Initiated PrEP
|
8 Participants
|
4 Participants
|
|
Changes in PrEP Uptake
Interval 3: 6-9 months · Did not initiate PrEP
|
127 Participants
|
124 Participants
|
|
Changes in PrEP Uptake
Interval 3: 6-9 months · Lost to follow up
|
1 Participants
|
3 Participants
|
|
Changes in PrEP Uptake
Interval 4: 9-12 months · Initiated PrEP
|
5 Participants
|
2 Participants
|
|
Changes in PrEP Uptake
Interval 4: 9-12 months · Did not initiate PrEP
|
122 Participants
|
122 Participants
|
|
Changes in PrEP Uptake
Interval 4: 9-12 months · Lost to follow up
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Every 3 months through study completion, up to 12 monthsPopulation: Individuals on PrEP at start of each interval
Persistence of pre-exposure prophylaxis, measured as sufficient pill dispensation for complete 3-month coverage with no more than 10 days uncovered in the period
Outcome measures
| Measure |
Immediate Intervention
n=70 Participants
Group to receive Manas Intervention (group and individual peer navigation) in Year 1 of the study
|
Delayed Intervention
n=63 Participants
Group to receive Manas Intervention (group and individual peer navigation) in Year 2 of the study
|
|---|---|---|
|
Changes in PrEP Persistence
Interval 1: 0-3 months · PrEP persistence
|
27 Participants
|
35 Participants
|
|
Changes in PrEP Persistence
Interval 1: 0-3 months · No persistence
|
16 Participants
|
10 Participants
|
|
Changes in PrEP Persistence
Interval 2: 3-6 months · PrEP persistence
|
19 Participants
|
19 Participants
|
|
Changes in PrEP Persistence
Interval 2: 3-6 months · No persistence
|
38 Participants
|
38 Participants
|
|
Changes in PrEP Persistence
Interval 3: 6-9 months · PrEP persistence
|
23 Participants
|
21 Participants
|
|
Changes in PrEP Persistence
Interval 3: 6-9 months · No persistence
|
42 Participants
|
40 Participants
|
|
Changes in PrEP Persistence
Interval 4: 9-12 months · PrEP persistence
|
18 Participants
|
24 Participants
|
|
Changes in PrEP Persistence
Interval 4: 9-12 months · No persistence
|
52 Participants
|
39 Participants
|
SECONDARY outcome
Timeframe: Every 3 months through study completion, up to 12 monthsPopulation: Participants contributed data for intervals in which they reported current PrEP use and presented to have a dried blood spot taken.
Drug levels in dried blood spots sufficient for protection against HIV acquisition (\>=800 TFV/FTC fmol/punch)
Outcome measures
| Measure |
Immediate Intervention
n=35 Participants
Group to receive Manas Intervention (group and individual peer navigation) in Year 1 of the study
|
Delayed Intervention
n=32 Participants
Group to receive Manas Intervention (group and individual peer navigation) in Year 2 of the study
|
|---|---|---|
|
Changes in PrEP Adherence
Interval 1: 0-3 months · Sufficient PrEP level
|
5 Participants
|
8 Participants
|
|
Changes in PrEP Adherence
Interval 1: 0-3 months · Insufficient PrEP level
|
4 Participants
|
2 Participants
|
|
Changes in PrEP Adherence
Interval 2: 3-6 months · Sufficient PrEP level
|
9 Participants
|
7 Participants
|
|
Changes in PrEP Adherence
Interval 2: 3-6 months · Insufficient PrEP level
|
3 Participants
|
9 Participants
|
|
Changes in PrEP Adherence
Interval 3: 6-9 months · Sufficient PrEP level
|
9 Participants
|
10 Participants
|
|
Changes in PrEP Adherence
Interval 3: 6-9 months · Insufficient PrEP level
|
9 Participants
|
6 Participants
|
|
Changes in PrEP Adherence
Interval 4: 9-12 months · Sufficient PrEP level
|
11 Participants
|
9 Participants
|
|
Changes in PrEP Adherence
Interval 4: 9-12 months · Insufficient PrEP level
|
7 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Every 3 months through study completion, up to 12 monthsPopulation: 12 participants did not complete a follow-up visit during Year 1; 32 participants had no reported sex partners during Year 1 and were excluded from the analysis.
Self-reported consistent condom use with regular and occasional partners and clients
Outcome measures
| Measure |
Immediate Intervention
n=171 Participants
Group to receive Manas Intervention (group and individual peer navigation) in Year 1 of the study
|
Delayed Intervention
n=177 Participants
Group to receive Manas Intervention (group and individual peer navigation) in Year 2 of the study
|
|---|---|---|
|
Changes in Condom Use
Interval 1: 0-3 months · Consistent condom use
|
63 Participants
|
69 Participants
|
|
Changes in Condom Use
Interval 1: 0-3 months · No consistent condom use
|
87 Participants
|
77 Participants
|
|
Changes in Condom Use
Interval 1: 0-3 months · Missing
|
1 Participants
|
3 Participants
|
|
Changes in Condom Use
Interval 2: 3-6 months · Consistent condom use
|
59 Participants
|
68 Participants
|
|
Changes in Condom Use
Interval 2: 3-6 months · No consistent condom use
|
83 Participants
|
74 Participants
|
|
Changes in Condom Use
Interval 2: 3-6 months · Missing
|
3 Participants
|
0 Participants
|
|
Changes in Condom Use
Interval 3: 6-9 months · Consistent condom use
|
57 Participants
|
64 Participants
|
|
Changes in Condom Use
Interval 3: 6-9 months · No consistent condom use
|
83 Participants
|
78 Participants
|
|
Changes in Condom Use
Interval 3: 6-9 months · Missing
|
0 Participants
|
2 Participants
|
|
Changes in Condom Use
Interval 4: 9-12 months · Consistent condom use
|
56 Participants
|
72 Participants
|
|
Changes in Condom Use
Interval 4: 9-12 months · No consistent condom use
|
88 Participants
|
77 Participants
|
|
Changes in Condom Use
Interval 4: 9-12 months · Missing
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Every 3 months through study completion, up to 12 monthsPopulation: 1 participant died prior to completing on follow-up data; 9 additional participants contributed no follow-up data in Year 1.
Self-reported and clinic-based receipt of STI care referral
Outcome measures
| Measure |
Immediate Intervention
n=193 Participants
Group to receive Manas Intervention (group and individual peer navigation) in Year 1 of the study
|
Delayed Intervention
n=189 Participants
Group to receive Manas Intervention (group and individual peer navigation) in Year 2 of the study
|
|---|---|---|
|
Changes in Utilization of Sexual Health Services
Interval 1: 0-3 months · Received referral for STI services
|
17 Participants
|
23 Participants
|
|
Changes in Utilization of Sexual Health Services
Interval 1: 0-3 months · Did not receive referral for STI services
|
171 Participants
|
157 Participants
|
|
Changes in Utilization of Sexual Health Services
Interval 2: 3-6 months · Did not receive referral for STI services
|
154 Participants
|
151 Participants
|
|
Changes in Utilization of Sexual Health Services
Interval 3: 6-9 months · Received referral for STI services
|
17 Participants
|
20 Participants
|
|
Changes in Utilization of Sexual Health Services
Interval 3: 6-9 months · Did not receive referral for STI services
|
162 Participants
|
154 Participants
|
|
Changes in Utilization of Sexual Health Services
Interval 4: 9-12 months · Received referral for STI services
|
25 Participants
|
25 Participants
|
|
Changes in Utilization of Sexual Health Services
Interval 4: 9-12 months · Did not receive referral for STI services
|
148 Participants
|
150 Participants
|
|
Changes in Utilization of Sexual Health Services
Interval 2: 3-6 months · Received referral for STI services
|
18 Participants
|
19 Participants
|
Adverse Events
Immediate Intervention
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
Delayed Intervention
Serious events: 7 serious events
Other events: 0 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Immediate Intervention
n=198 participants at risk
Group to receive Manas Intervention (group and individual peer navigation) in Year 1 of the study
|
Delayed Intervention
n=194 participants at risk
Group to receive Manas Intervention (group and individual peer navigation) in Year 2 of the study
|
|---|---|---|
|
Immune system disorders
First positive test for Human Immunodeficiency Virus
|
0.51%
1/198 • Number of events 1 • 2 years
All-Cause Mortality: Clinicaltrials.gov definition. Serious Adverse Events: Clinicaltrials.gov definition. Note that we have included HIV seroconversion as HIV can be life-threatening if not properly treated and it does require medical intervention. Other (Not Including Serious) Adverse Events: Clinicaltrials.gov definition
|
3.6%
7/194 • Number of events 7 • 2 years
All-Cause Mortality: Clinicaltrials.gov definition. Serious Adverse Events: Clinicaltrials.gov definition. Note that we have included HIV seroconversion as HIV can be life-threatening if not properly treated and it does require medical intervention. Other (Not Including Serious) Adverse Events: Clinicaltrials.gov definition
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Sheri A Lippman
University of California, San Francisco
Phone: 4154762300
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place