Trial Outcomes & Findings for HIV Treatment Retention Interventions for Women Living With HIV (Siyaphambili Study) (NCT NCT03500172)
NCT ID: NCT03500172
Last Updated: 2026-01-14
Results Overview
Retention and viral suppression at 18 months in those initially randomized to DTP vs. ICM. Participants are considered to be retained in care if they attended their 18-month final study visit and were engaged in care at 18-months. Viral suppression is defined as having less than 50 viral copies per milliliter.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1391 participants
Primary outcome timeframe
18 months after enrollment
Results posted on
2026-01-14
Participant Flow
Recruitment took place at sex work venues and the TB HIV Care drop-in center in Durban, South Africa from June 2018 to March 2020. The first participant was enrolled on June 22, 2018 and the last participant was enrolled on March 23, 2020.
Of the 1391 participants enrolled, 777 met randomization criteria (non-virally suppressed) and were randomized to one of the two tested strategies. Participants who were virally suppressed at baseline OR lost to follow up prior to baseline randomization (n=614) continued with standard of care and were not randomized.
Participant milestones
| Measure |
DTP, Continue DTP if Responsive
DTP:
* Standard of care, minus clinic referrals for ART treatment initiation and management.
* Nurse initiated and managed ART within the community on mobile van at sites served by the mobile van which already provides SoC services
Continues with DTP intervention if virally suppressed at 6 months.
DTP: Provision of antiretroviral therapy (ART) in the community through a mobile-van DTP managed by a nurse capable of initiating and managing ART.
|
DTP, Standard of Care (SoC) if Responsive
DTP:
* Standard of care, minus clinic referrals for ART treatment initiation and management.
* Nurse initiated and managed ART within the community on mobile van at sites served by the mobile van which already provides SoC services
SoC:
* HIV counseling and testing (HTC)
* STI screening and treatment
* TB screening and referral
* Health education through peer educators and peer supported follow-up related to linkages to care
* Referrals to DOH primary healthcare clinics or THC drop-in center for ART treatment initiation and management
Returns to SoC if virally suppressed at 6 months.
DTP: Provision of antiretroviral therapy (ART) in the community through a mobile-van DTP managed by a nurse capable of initiating and managing ART.
|
DTP, Continue DTP if Non-Responsive
DTP:
* Standard of care, minus clinic referrals for ART treatment initiation and management.
* Nurse initiated and managed ART within the community on mobile van at sites served by the mobile van which already provides SoC services
Continues with DTP intervention if not virally suppressed at 6 months.
DTP: Provision of antiretroviral therapy (ART) in the community through a mobile-van DTP managed by a nurse capable of initiating and managing ART.
|
DTP, DTP+ICM if Non-Responsive
DTP:
* Standard of care, minus clinic referrals for ART treatment initiation and management.
* Nurse initiated and managed ART within the community on mobile van at sites served by the mobile van which already provides SoC services
Receives both interventions at 6 months if non-virally suppressed.
DTP: Provision of antiretroviral therapy (ART) in the community through a mobile-van DTP managed by a nurse capable of initiating and managing ART.
ICM: Peer-led ICM through quarterly face-to-face meetings, monthly phone calls and biweekly text messages.
|
ICM, Continue ICM if Responsive
ICM:
* Standard of Care
* Assignment of peer case manager
* Face-to-face meeting to tailor ICM approach to FSW preference
* Self-efficacy building in face-to-face sessions and bi-weekly text messages
* Relational support through monthly calls, face-to-face meetings every three months, and additional support through FSW initiated interaction
Continues with ICM intervention at 6 months if virally suppressed.
ICM: Peer-led ICM through quarterly face-to-face meetings, monthly phone calls and biweekly text messages.
|
ICM, SoC if Responsive
ICM:
* Standard of Care
* Assignment of peer case manager
* Face-to-face meeting to tailor ICM approach to FSW preference
* Self-efficacy building in face-to-face sessions and bi-weekly text messages
* Relational support through monthly calls, face-to-face meetings every three months, and additional support through FSW initiated interaction
SoC:
* HIV counseling and testing (HTC)
* STI screening and treatment
* TB screening and referral
* Health education through peer educators and peer supported follow-up related to linkages to care
* Referrals to DOH primary healthcare clinics or THC drop-in center for ART treatment initiation and management
Returns to SoC if virally suppressed at 6 months.
ICM: Peer-led ICM through quarterly face-to-face meetings, monthly phone calls and biweekly text messages.
|
ICM, Continue ICM if Non-Responsive
ICM:
* Standard of Care
* Assignment of peer case manager
* Face-to-face meeting to tailor ICM approach to FSW preference
* Self-efficacy building in face-to-face sessions and bi-weekly text messages
* Relational support through monthly calls, face-to-face meetings every three months, and additional support through FSW initiated interaction
Continues with ICM intervention at 6 months if non-virally suppressed.
ICM: Peer-led ICM through quarterly face-to-face meetings, monthly phone calls and biweekly text messages.
|
ICM, ICM+DTP if Non-Responsive
ICM:
* Standard of Care
* Assignment of peer case manager
* Face-to-face meeting to tailor ICM approach to FSW preference
* Self-efficacy building in face-to-face sessions and bi-weekly text messages
* Relational support through monthly calls, face-to-face meetings every three months, and additional support through FSW initiated interaction
DTP:
* Standard of care, minus clinic referrals for ART treatment initiation and management.
* Nurse initiated and managed ART within the community on mobile van at sites served by the mobile van which already provides SoC services
Receives both interventions at 6 months if non-virally suppressed.
DTP: Provision of antiretroviral therapy (ART) in the community through a mobile-van DTP managed by a nurse capable of initiating and managing ART.
ICM: Peer-led ICM through quarterly face-to-face meetings, monthly phone calls and biweekly text messages.
|
Standard of Care (SoC)
SoC (virally suppressed at baseline OR lost to follow up prior to baseline randomization):
* HIV counseling and testing (HTC)
* STI screening and treatment
* TB screening and referral
* Health education through peer educators and peer supported follow-up related to linkages to care
* Referrals to DOH primary healthcare clinics or THC drop-in center for ART treatment initiation and management
|
Baseline Randomization: ICM
ICM:
* Standard of Care
* Assignment of peer case manager
* Face-to-face meeting to tailor ICM approach to FSW preference
* Self-efficacy building in face-to-face sessions and bi-weekly text messages
* Relational support through monthly calls, face-to-face meetings every three months, and additional support through FSW initiated interaction
|
Baseline Randomization: DTP
DTP:
* Standard of care, minus clinic referrals for ART treatment initiation and management.
* Nurse initiated and managed ART within the community on mobile van at sites served by the mobile van which already provides SoC services
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Period 1: Baseline Randomization
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
614
|
390
|
387
|
|
Period 1: Baseline Randomization
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
614
|
387
|
387
|
|
Period 1: Baseline Randomization
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
0
|
|
Period 2: Re-Randomization
STARTED
|
27
|
24
|
171
|
165
|
20
|
27
|
177
|
163
|
614
|
0
|
0
|
|
Period 2: Re-Randomization
COMPLETED
|
19
|
18
|
84
|
93
|
14
|
21
|
109
|
87
|
614
|
0
|
0
|
|
Period 2: Re-Randomization
NOT COMPLETED
|
8
|
6
|
87
|
72
|
6
|
6
|
68
|
76
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
DTP, Continue DTP if Responsive
DTP:
* Standard of care, minus clinic referrals for ART treatment initiation and management.
* Nurse initiated and managed ART within the community on mobile van at sites served by the mobile van which already provides SoC services
Continues with DTP intervention if virally suppressed at 6 months.
DTP: Provision of antiretroviral therapy (ART) in the community through a mobile-van DTP managed by a nurse capable of initiating and managing ART.
|
DTP, Standard of Care (SoC) if Responsive
DTP:
* Standard of care, minus clinic referrals for ART treatment initiation and management.
* Nurse initiated and managed ART within the community on mobile van at sites served by the mobile van which already provides SoC services
SoC:
* HIV counseling and testing (HTC)
* STI screening and treatment
* TB screening and referral
* Health education through peer educators and peer supported follow-up related to linkages to care
* Referrals to DOH primary healthcare clinics or THC drop-in center for ART treatment initiation and management
Returns to SoC if virally suppressed at 6 months.
DTP: Provision of antiretroviral therapy (ART) in the community through a mobile-van DTP managed by a nurse capable of initiating and managing ART.
|
DTP, Continue DTP if Non-Responsive
DTP:
* Standard of care, minus clinic referrals for ART treatment initiation and management.
* Nurse initiated and managed ART within the community on mobile van at sites served by the mobile van which already provides SoC services
Continues with DTP intervention if not virally suppressed at 6 months.
DTP: Provision of antiretroviral therapy (ART) in the community through a mobile-van DTP managed by a nurse capable of initiating and managing ART.
|
DTP, DTP+ICM if Non-Responsive
DTP:
* Standard of care, minus clinic referrals for ART treatment initiation and management.
* Nurse initiated and managed ART within the community on mobile van at sites served by the mobile van which already provides SoC services
Receives both interventions at 6 months if non-virally suppressed.
DTP: Provision of antiretroviral therapy (ART) in the community through a mobile-van DTP managed by a nurse capable of initiating and managing ART.
ICM: Peer-led ICM through quarterly face-to-face meetings, monthly phone calls and biweekly text messages.
|
ICM, Continue ICM if Responsive
ICM:
* Standard of Care
* Assignment of peer case manager
* Face-to-face meeting to tailor ICM approach to FSW preference
* Self-efficacy building in face-to-face sessions and bi-weekly text messages
* Relational support through monthly calls, face-to-face meetings every three months, and additional support through FSW initiated interaction
Continues with ICM intervention at 6 months if virally suppressed.
ICM: Peer-led ICM through quarterly face-to-face meetings, monthly phone calls and biweekly text messages.
|
ICM, SoC if Responsive
ICM:
* Standard of Care
* Assignment of peer case manager
* Face-to-face meeting to tailor ICM approach to FSW preference
* Self-efficacy building in face-to-face sessions and bi-weekly text messages
* Relational support through monthly calls, face-to-face meetings every three months, and additional support through FSW initiated interaction
SoC:
* HIV counseling and testing (HTC)
* STI screening and treatment
* TB screening and referral
* Health education through peer educators and peer supported follow-up related to linkages to care
* Referrals to DOH primary healthcare clinics or THC drop-in center for ART treatment initiation and management
Returns to SoC if virally suppressed at 6 months.
ICM: Peer-led ICM through quarterly face-to-face meetings, monthly phone calls and biweekly text messages.
|
ICM, Continue ICM if Non-Responsive
ICM:
* Standard of Care
* Assignment of peer case manager
* Face-to-face meeting to tailor ICM approach to FSW preference
* Self-efficacy building in face-to-face sessions and bi-weekly text messages
* Relational support through monthly calls, face-to-face meetings every three months, and additional support through FSW initiated interaction
Continues with ICM intervention at 6 months if non-virally suppressed.
ICM: Peer-led ICM through quarterly face-to-face meetings, monthly phone calls and biweekly text messages.
|
ICM, ICM+DTP if Non-Responsive
ICM:
* Standard of Care
* Assignment of peer case manager
* Face-to-face meeting to tailor ICM approach to FSW preference
* Self-efficacy building in face-to-face sessions and bi-weekly text messages
* Relational support through monthly calls, face-to-face meetings every three months, and additional support through FSW initiated interaction
DTP:
* Standard of care, minus clinic referrals for ART treatment initiation and management.
* Nurse initiated and managed ART within the community on mobile van at sites served by the mobile van which already provides SoC services
Receives both interventions at 6 months if non-virally suppressed.
DTP: Provision of antiretroviral therapy (ART) in the community through a mobile-van DTP managed by a nurse capable of initiating and managing ART.
ICM: Peer-led ICM through quarterly face-to-face meetings, monthly phone calls and biweekly text messages.
|
Standard of Care (SoC)
SoC (virally suppressed at baseline OR lost to follow up prior to baseline randomization):
* HIV counseling and testing (HTC)
* STI screening and treatment
* TB screening and referral
* Health education through peer educators and peer supported follow-up related to linkages to care
* Referrals to DOH primary healthcare clinics or THC drop-in center for ART treatment initiation and management
|
Baseline Randomization: ICM
ICM:
* Standard of Care
* Assignment of peer case manager
* Face-to-face meeting to tailor ICM approach to FSW preference
* Self-efficacy building in face-to-face sessions and bi-weekly text messages
* Relational support through monthly calls, face-to-face meetings every three months, and additional support through FSW initiated interaction
|
Baseline Randomization: DTP
DTP:
* Standard of care, minus clinic referrals for ART treatment initiation and management.
* Nurse initiated and managed ART within the community on mobile van at sites served by the mobile van which already provides SoC services
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Period 1: Baseline Randomization
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
|
Period 1: Baseline Randomization
Protocol Violation
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Period 2: Re-Randomization
Lost to Follow-up
|
8
|
6
|
87
|
68
|
4
|
6
|
63
|
74
|
0
|
0
|
0
|
|
Period 2: Re-Randomization
Death
|
0
|
0
|
0
|
4
|
2
|
0
|
5
|
2
|
0
|
0
|
0
|
Baseline Characteristics
HIV Treatment Retention Interventions for Women Living With HIV (Siyaphambili Study)
Baseline characteristics by cohort
| Measure |
Standard of Care (Virally Suppressed at Baseline OR Lost to Follow up Before Baseline Randomization)
n=614 Participants
SoC (virally suppressed at baseline OR lost to follow up prior to baseline randomization):
* HIV counseling and testing (HTC)
* STI screening and treatment
* TB screening and referral
* Health education through peer educators and peer supported follow-up related to linkages to care
* Referrals to DOH primary healthcare clinics or THC drop-in center for ART treatment initiation and management
|
Total
n=1391 Participants
Total of all reporting groups
|
Individualized Case Management (ICM) at Baseline
n=390 Participants
ICM:
* Standard of Care
* Assignment of peer case manager
* Face-to-face meeting to tailor ICM approach to FSW preference
* Self-efficacy building in face-to-face sessions and bi-weekly text messages
* Relational support through monthly calls, face-to-face meetings every three months, and additional support through FSW initiated interaction
|
Decentralized Treatment Provision (DTP) at Baseline
n=387 Participants
DTP:
* Standard of care (SoC), minus clinic referrals for antiretroviral therapy (ART) treatment initiation and management.
* Nurse initiated and managed ART within the community on mobile van at sites served by the mobile van which already provides SoC services
|
|---|---|---|---|---|
|
Age, Customized
Age · 18-24
|
78 Participants
n=24 Participants
|
202 Participants
n=78 Participants
|
60 Participants
n=14 Participants
|
64 Participants
n=10 Participants
|
|
Age, Customized
Age · 25-29
|
119 Participants
n=24 Participants
|
377 Participants
n=78 Participants
|
135 Participants
n=14 Participants
|
123 Participants
n=10 Participants
|
|
Age, Customized
Age · 30-35
|
172 Participants
n=24 Participants
|
402 Participants
n=78 Participants
|
113 Participants
n=14 Participants
|
117 Participants
n=10 Participants
|
|
Age, Customized
Age · 35+
|
240 Participants
n=24 Participants
|
404 Participants
n=78 Participants
|
82 Participants
n=14 Participants
|
82 Participants
n=10 Participants
|
|
Age, Customized
Age · Missing
|
5 Participants
n=24 Participants
|
6 Participants
n=78 Participants
|
0 Participants
n=14 Participants
|
1 Participants
n=10 Participants
|
|
Sex: Female, Male
Female
|
614 Participants
n=24 Participants
|
1391 Participants
n=78 Participants
|
390 Participants
n=14 Participants
|
387 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=24 Participants
|
0 Participants
n=78 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=24 Participants
|
0 Participants
n=78 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=24 Participants
|
3 Participants
n=78 Participants
|
0 Participants
n=14 Participants
|
2 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=24 Participants
|
0 Participants
n=78 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
594 Participants
n=24 Participants
|
1341 Participants
n=78 Participants
|
375 Participants
n=14 Participants
|
372 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=24 Participants
|
0 Participants
n=78 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
10 Participants
n=24 Participants
|
35 Participants
n=78 Participants
|
13 Participants
n=14 Participants
|
12 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=24 Participants
|
12 Participants
n=78 Participants
|
2 Participants
n=14 Participants
|
1 Participants
n=10 Participants
|
|
Region of Enrollment
South Africa
|
614 Participants
n=24 Participants
|
1391 Participants
n=78 Participants
|
390 Participants
n=14 Participants
|
387 Participants
n=10 Participants
|
|
Nationality
South African
|
595 Participants
n=24 Participants
|
1354 Participants
n=78 Participants
|
379 Participants
n=14 Participants
|
380 Participants
n=10 Participants
|
|
Nationality
Other (Incl. Lesotho, Eswatini, Zimbabwe, Botswana)
|
19 Participants
n=24 Participants
|
37 Participants
n=78 Participants
|
11 Participants
n=14 Participants
|
7 Participants
n=10 Participants
|
|
Education
Never attended
|
15 Participants
n=24 Participants
|
25 Participants
n=78 Participants
|
4 Participants
n=14 Participants
|
6 Participants
n=10 Participants
|
|
Education
Complete/incomplete primary education
|
79 Participants
n=24 Participants
|
136 Participants
n=78 Participants
|
29 Participants
n=14 Participants
|
28 Participants
n=10 Participants
|
|
Education
Secondary school incomplete
|
394 Participants
n=24 Participants
|
955 Participants
n=78 Participants
|
283 Participants
n=14 Participants
|
278 Participants
n=10 Participants
|
|
Education
Secondary school complete
|
98 Participants
n=24 Participants
|
219 Participants
n=78 Participants
|
54 Participants
n=14 Participants
|
67 Participants
n=10 Participants
|
|
Education
Any post-secondary education or technical training
|
19 Participants
n=24 Participants
|
44 Participants
n=78 Participants
|
18 Participants
n=14 Participants
|
7 Participants
n=10 Participants
|
|
Education
Missing
|
9 Participants
n=24 Participants
|
12 Participants
n=78 Participants
|
2 Participants
n=14 Participants
|
1 Participants
n=10 Participants
|
|
Currently enrolled in school
Currently enrolled in school
|
9 Participants
n=24 Participants
|
12 Participants
n=78 Participants
|
2 Participants
n=14 Participants
|
1 Participants
n=10 Participants
|
|
Currently enrolled in school
Not currently enrolled in school
|
605 Participants
n=24 Participants
|
1379 Participants
n=78 Participants
|
388 Participants
n=14 Participants
|
386 Participants
n=10 Participants
|
|
Can read and/or write in Zulu or English
|
585 Participants
n=24 Participants
|
1346 Participants
n=78 Participants
|
382 Participants
n=14 Participants
|
379 Participants
n=10 Participants
|
|
Current employment other than sex work
None
|
561 Participants
n=24 Participants
|
1298 Participants
n=78 Participants
|
371 Participants
n=14 Participants
|
366 Participants
n=10 Participants
|
|
Current employment other than sex work
Self-employed (formal or informal)
|
33 Participants
n=24 Participants
|
63 Participants
n=78 Participants
|
14 Participants
n=14 Participants
|
16 Participants
n=10 Participants
|
|
Current employment other than sex work
Private or public employed
|
10 Participants
n=24 Participants
|
15 Participants
n=78 Participants
|
2 Participants
n=14 Participants
|
3 Participants
n=10 Participants
|
|
Current employment other than sex work
Refusal
|
0 Participants
n=24 Participants
|
1 Participants
n=78 Participants
|
0 Participants
n=14 Participants
|
1 Participants
n=10 Participants
|
|
Current employment other than sex work
Missing
|
10 Participants
n=24 Participants
|
14 Participants
n=78 Participants
|
3 Participants
n=14 Participants
|
1 Participants
n=10 Participants
|
|
Relationship status
Steady partner, living together
|
86 Participants
n=24 Participants
|
209 Participants
n=78 Participants
|
59 Participants
n=14 Participants
|
64 Participants
n=10 Participants
|
|
Relationship status
Steady partner, not living together
|
221 Participants
n=24 Participants
|
471 Participants
n=78 Participants
|
116 Participants
n=14 Participants
|
134 Participants
n=10 Participants
|
|
Relationship status
Single
|
298 Participants
n=24 Participants
|
699 Participants
n=78 Participants
|
213 Participants
n=14 Participants
|
188 Participants
n=10 Participants
|
|
Relationship status
Missing
|
9 Participants
n=24 Participants
|
12 Participants
n=78 Participants
|
2 Participants
n=14 Participants
|
1 Participants
n=10 Participants
|
|
Median age at first sex
|
17 years
n=24 Participants
|
17 years
n=78 Participants
|
16 years
n=14 Participants
|
17 years
n=10 Participants
|
|
Median age at first exchange of sex acts for goods
|
23 years
n=24 Participants
|
22 years
n=78 Participants
|
22 years
n=14 Participants
|
22 years
n=10 Participants
|
|
Median age at first exchange of sex acts for money
|
23 years
n=24 Participants
|
23 years
n=78 Participants
|
22 years
n=14 Participants
|
22 years
n=10 Participants
|
|
Advertises service online
|
29 Participants
n=24 Participants
|
54 Participants
n=78 Participants
|
15 Participants
n=14 Participants
|
10 Participants
n=10 Participants
|
|
Always carries condoms while working
|
529 Participants
n=24 Participants
|
1203 Participants
n=78 Participants
|
341 Participants
n=14 Participants
|
333 Participants
n=10 Participants
|
|
Consistent condom use with new clients (last 30 days)
Consistent
|
371 Participants
n=24 Participants
|
820 Participants
n=78 Participants
|
223 Participants
n=14 Participants
|
226 Participants
n=10 Participants
|
|
Consistent condom use with new clients (last 30 days)
Inconsistent
|
210 Participants
n=24 Participants
|
501 Participants
n=78 Participants
|
145 Participants
n=14 Participants
|
146 Participants
n=10 Participants
|
|
Consistent condom use with new clients (last 30 days)
Refusal/missing
|
15 Participants
n=24 Participants
|
32 Participants
n=78 Participants
|
10 Participants
n=14 Participants
|
7 Participants
n=10 Participants
|
|
Consistent condom use with new clients (last 30 days)
Did not have sex with a new client in last 30 days
|
18 Participants
n=24 Participants
|
38 Participants
n=78 Participants
|
12 Participants
n=14 Participants
|
8 Participants
n=10 Participants
|
|
Consistent condom use with regular clients (last 30 days)
Consistent
|
312 Participants
n=24 Participants
|
681 Participants
n=78 Participants
|
183 Participants
n=14 Participants
|
186 Participants
n=10 Participants
|
|
Consistent condom use with regular clients (last 30 days)
Inconsistent
|
260 Participants
n=24 Participants
|
613 Participants
n=78 Participants
|
179 Participants
n=14 Participants
|
174 Participants
n=10 Participants
|
|
Consistent condom use with regular clients (last 30 days)
Refusal/missing
|
17 Participants
n=24 Participants
|
35 Participants
n=78 Participants
|
11 Participants
n=14 Participants
|
7 Participants
n=10 Participants
|
|
Consistent condom use with regular clients (last 30 days)
Did not have sex with a regular client in the last 30 days
|
25 Participants
n=24 Participants
|
62 Participants
n=78 Participants
|
17 Participants
n=14 Participants
|
20 Participants
n=10 Participants
|
|
Consistent condom use with non-paying partners (last 30 days)
Consistent
|
77 Participants
n=24 Participants
|
169 Participants
n=78 Participants
|
55 Participants
n=14 Participants
|
37 Participants
n=10 Participants
|
|
Consistent condom use with non-paying partners (last 30 days)
Inconsistent
|
256 Participants
n=24 Participants
|
559 Participants
n=78 Participants
|
138 Participants
n=14 Participants
|
165 Participants
n=10 Participants
|
|
Consistent condom use with non-paying partners (last 30 days)
No sex with non-paying partner in past 30 days
|
264 Participants
n=24 Participants
|
636 Participants
n=78 Participants
|
190 Participants
n=14 Participants
|
182 Participants
n=10 Participants
|
|
Consistent condom use with non-paying partners (last 30 days)
Refusal/missing
|
17 Participants
n=24 Participants
|
27 Participants
n=78 Participants
|
7 Participants
n=14 Participants
|
3 Participants
n=10 Participants
|
|
Hormonal contraception
|
236 Participants
n=24 Participants
|
485 Participants
n=78 Participants
|
130 Participants
n=14 Participants
|
119 Participants
n=10 Participants
|
|
Non-hormonal contraception
|
588 Participants
n=24 Participants
|
1343 Participants
n=78 Participants
|
378 Participants
n=14 Participants
|
377 Participants
n=10 Participants
|
|
Parity
Nulliparous/No live births
|
105 Participants
n=24 Participants
|
278 Participants
n=78 Participants
|
90 Participants
n=14 Participants
|
83 Participants
n=10 Participants
|
|
Parity
One live birth
|
182 Participants
n=24 Participants
|
454 Participants
n=78 Participants
|
136 Participants
n=14 Participants
|
136 Participants
n=10 Participants
|
|
Parity
Two live births
|
142 Participants
n=24 Participants
|
324 Participants
n=78 Participants
|
96 Participants
n=14 Participants
|
86 Participants
n=10 Participants
|
|
Parity
Three or more live births
|
183 Participants
n=24 Participants
|
332 Participants
n=78 Participants
|
68 Participants
n=14 Participants
|
81 Participants
n=10 Participants
|
|
Parity
Missing
|
2 Participants
n=24 Participants
|
3 Participants
n=78 Participants
|
0 Participants
n=14 Participants
|
1 Participants
n=10 Participants
|
|
Tested for tuberculosis in last 6 months
|
374 Participants
n=24 Participants
|
825 Participants
n=78 Participants
|
224 Participants
n=14 Participants
|
227 Participants
n=10 Participants
|
|
Hospitalized in last 6 months
|
76 Participants
n=24 Participants
|
156 Participants
n=78 Participants
|
40 Participants
n=14 Participants
|
40 Participants
n=10 Participants
|
|
Antiretroviral therapy experience
ART Naive
|
37 Participants
n=24 Participants
|
179 Participants
n=78 Participants
|
70 Participants
n=14 Participants
|
72 Participants
n=10 Participants
|
|
Antiretroviral therapy experience
Ever Initiated
|
573 Participants
n=24 Participants
|
1208 Participants
n=78 Participants
|
320 Participants
n=14 Participants
|
315 Participants
n=10 Participants
|
|
Antiretroviral therapy experience
Missing
|
4 Participants
n=24 Participants
|
4 Participants
n=78 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=10 Participants
|
|
Ever experienced physical abuse
|
297 Participants
n=24 Participants
|
743 Participants
n=78 Participants
|
231 Participants
n=14 Participants
|
215 Participants
n=10 Participants
|
|
Ever experienced sexual abuse
|
192 Participants
n=24 Participants
|
517 Participants
n=78 Participants
|
159 Participants
n=14 Participants
|
166 Participants
n=10 Participants
|
|
Median self-reported health state
|
56 units on a scale
n=24 Participants
|
52 units on a scale
n=78 Participants
|
51 units on a scale
n=14 Participants
|
51 units on a scale
n=10 Participants
|
|
Baseline viral load
Greater than 1000 copies/mL (non-virally suppressed)
|
52 Participants
n=24 Participants
|
646 Participants
n=78 Participants
|
294 Participants
n=14 Participants
|
300 Participants
n=10 Participants
|
|
Depression
No/minimal depression
|
114 Participants
n=24 Participants
|
258 Participants
n=78 Participants
|
66 Participants
n=14 Participants
|
78 Participants
n=10 Participants
|
|
Depression
Mild depression
|
287 Participants
n=24 Participants
|
641 Participants
n=78 Participants
|
178 Participants
n=14 Participants
|
176 Participants
n=10 Participants
|
|
Depression
Moderate depression
|
89 Participants
n=24 Participants
|
188 Participants
n=78 Participants
|
47 Participants
n=14 Participants
|
52 Participants
n=10 Participants
|
|
Depression
Moderately severe depression
|
67 Participants
n=24 Participants
|
193 Participants
n=78 Participants
|
72 Participants
n=14 Participants
|
54 Participants
n=10 Participants
|
|
Depression
Severe depression
|
37 Participants
n=24 Participants
|
81 Participants
n=78 Participants
|
22 Participants
n=14 Participants
|
22 Participants
n=10 Participants
|
|
Depression
Missing
|
20 Participants
n=24 Participants
|
30 Participants
n=78 Participants
|
5 Participants
n=14 Participants
|
5 Participants
n=10 Participants
|
|
Drinks alcohol two or more times a week
|
240 Participants
n=24 Participants
|
568 Participants
n=78 Participants
|
165 Participants
n=14 Participants
|
163 Participants
n=10 Participants
|
|
Ever injected drugs
|
13 Participants
n=24 Participants
|
57 Participants
n=78 Participants
|
23 Participants
n=14 Participants
|
21 Participants
n=10 Participants
|
|
Baseline viral load
Less than 50 copies/mL (virally suppressed)
|
523 Participants
n=24 Participants
|
523 Participants
n=78 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=10 Participants
|
|
Baseline viral load
50 to 1000 copies/mL (non-virally suppressed)
|
28 Participants
n=24 Participants
|
211 Participants
n=78 Participants
|
96 Participants
n=14 Participants
|
87 Participants
n=10 Participants
|
|
Baseline viral load
Missing
|
11 Participants
n=24 Participants
|
11 Participants
n=78 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: 18 months after enrollmentPopulation: This outcome is presented as an intention to treat analysis based on baseline randomization (DTP vs. ICM). All 777 participants randomized at baseline are included here.
Retention and viral suppression at 18 months in those initially randomized to DTP vs. ICM. Participants are considered to be retained in care if they attended their 18-month final study visit and were engaged in care at 18-months. Viral suppression is defined as having less than 50 viral copies per milliliter.
Outcome measures
| Measure |
Decentralized Treatment Provision (DTP) at Baseline
n=387 Participants
DTP:
* Standard of care, minus clinic referrals for ART treatment initiation and management.
* Nurse initiated and managed ART within the community on mobile van at sites served by the mobile van which already provides SoC services
|
Individualized Case Management (ICM) at Baseline
n=390 Participants
ICM:
* Standard of Care
* Assignment of peer case manager
* Face-to-face meeting to tailor ICM approach to FSW preference
* Self-efficacy building in face-to-face sessions and bi-weekly text messages
* Relational support through monthly calls, face-to-face meetings every three months, and additional support through FSW initiated interaction
|
|---|---|---|
|
Percentage of Participants Retained and Virally Suppressed Among Those Receiving the DTP Versus ICM Arms
|
16.0 percentage of participants
Interval 12.4 to 19.7
|
14.1 percentage of participants
Interval 10.6 to 17.6
|
SECONDARY outcome
Timeframe: 18 months after enrollmentPopulation: This outcome was specified as a comparison of two subgroups rather than overall sample. This is why only two groups are included in this outcome and the number of participants is smaller than the total sample.
Retention and viral suppression at 18 months among month 6 non-responders randomized to continuation of either intervention vs. combined DTP+ICM
Outcome measures
| Measure |
Decentralized Treatment Provision (DTP) at Baseline
n=351 Participants
DTP:
* Standard of care, minus clinic referrals for ART treatment initiation and management.
* Nurse initiated and managed ART within the community on mobile van at sites served by the mobile van which already provides SoC services
|
Individualized Case Management (ICM) at Baseline
n=328 Participants
ICM:
* Standard of Care
* Assignment of peer case manager
* Face-to-face meeting to tailor ICM approach to FSW preference
* Self-efficacy building in face-to-face sessions and bi-weekly text messages
* Relational support through monthly calls, face-to-face meetings every three months, and additional support through FSW initiated interaction
|
|---|---|---|
|
Retention and Viral Suppression of Non-Responders
|
11.4 percentage of participants
Interval 8.1 to 14.7
|
11.3 percentage of participants
Interval 7.9 to 14.7
|
SECONDARY outcome
Timeframe: Up to 18 months after enrollmentPopulation: Risk factors for loss to follow up were analyzed across the sample, not by randomization assignment. Groups here reflect this approach.
Risk stratification to identify FSW at highest risk for loss to follow-up.
Outcome measures
| Measure |
Decentralized Treatment Provision (DTP) at Baseline
n=578 Participants
DTP:
* Standard of care, minus clinic referrals for ART treatment initiation and management.
* Nurse initiated and managed ART within the community on mobile van at sites served by the mobile van which already provides SoC services
|
Individualized Case Management (ICM) at Baseline
n=199 Participants
ICM:
* Standard of Care
* Assignment of peer case manager
* Face-to-face meeting to tailor ICM approach to FSW preference
* Self-efficacy building in face-to-face sessions and bi-weekly text messages
* Relational support through monthly calls, face-to-face meetings every three months, and additional support through FSW initiated interaction
|
|---|---|---|
|
Risk Factors of Loss to Follow-up
Steady partner, living together
|
87 Participants
|
36 Participants
|
|
Risk Factors of Loss to Follow-up
5 to 9 new clients in the past month
|
159 Participants
|
40 Participants
|
|
Risk Factors of Loss to Follow-up
Marijuana use in the past 30 days
|
227 Participants
|
66 Participants
|
|
Risk Factors of Loss to Follow-up
Experienced physical violence in the pasts 6 months
|
338 Participants
|
103 Participants
|
|
Risk Factors of Loss to Follow-up
Experienced sexual violence in the past 6 months
|
250 Participants
|
73 Participants
|
|
Risk Factors of Loss to Follow-up
Viral load of 50-1000 copies/mL at baseline
|
130 Participants
|
54 Participants
|
|
Risk Factors of Loss to Follow-up
Viral load greater than 1000 copies/mL at baseline
|
448 Participants
|
145 Participants
|
SECONDARY outcome
Timeframe: Up to 18 months after enrollmentPopulation: This is a subgroup analysis of two of the month 6 re-randomization arms rather than the entire sample. Groups listed here and sample sizes reflect this approach.
Durability of retention and viral suppression among 6 month responders continuing on DTP or ICM vs. those randomized to revert to standard of care (SoC)
Outcome measures
| Measure |
Decentralized Treatment Provision (DTP) at Baseline
n=22 Participants
DTP:
* Standard of care, minus clinic referrals for ART treatment initiation and management.
* Nurse initiated and managed ART within the community on mobile van at sites served by the mobile van which already provides SoC services
|
Individualized Case Management (ICM) at Baseline
n=18 Participants
ICM:
* Standard of Care
* Assignment of peer case manager
* Face-to-face meeting to tailor ICM approach to FSW preference
* Self-efficacy building in face-to-face sessions and bi-weekly text messages
* Relational support through monthly calls, face-to-face meetings every three months, and additional support through FSW initiated interaction
|
|---|---|---|
|
Durability of Retention and Viral Suppression of Responders
|
43.1 percentage of participants
Interval 29.5 to 56.7
|
40.0 percentage of participants
Interval 25.7 to 54.3
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: This outcome was analyzed by baseline randomization status rather than month 6 re-randomization status. Groups included here reflect this. Numbers analyzed are smaller due to the fact that there was loss to follow up and not all participants answered questions on self-reported adherence.
Self-reported adherence to assess adherence across arms
Outcome measures
| Measure |
Decentralized Treatment Provision (DTP) at Baseline
n=200 Participants
DTP:
* Standard of care, minus clinic referrals for ART treatment initiation and management.
* Nurse initiated and managed ART within the community on mobile van at sites served by the mobile van which already provides SoC services
|
Individualized Case Management (ICM) at Baseline
n=223 Participants
ICM:
* Standard of Care
* Assignment of peer case manager
* Face-to-face meeting to tailor ICM approach to FSW preference
* Self-efficacy building in face-to-face sessions and bi-weekly text messages
* Relational support through monthly calls, face-to-face meetings every three months, and additional support through FSW initiated interaction
|
|---|---|---|
|
Adherence Assessment
|
46.5 percentage of participants
Interval 39.6 to 53.4
|
51.6 percentage of participants
Interval 45.0 to 58.2
|
SECONDARY outcome
Timeframe: Up to 18 months after enrollmentPopulation: This outcome was analyzed by baseline randomization status (DTP vs. ICM). Number of participants included reflects the total number retained in care across the two arms, which is less than the original sample size due to loss to follow up.
Among those retained, comparison of viral suppression across arms
Outcome measures
| Measure |
Decentralized Treatment Provision (DTP) at Baseline
n=214 Participants
DTP:
* Standard of care, minus clinic referrals for ART treatment initiation and management.
* Nurse initiated and managed ART within the community on mobile van at sites served by the mobile van which already provides SoC services
|
Individualized Case Management (ICM) at Baseline
n=231 Participants
ICM:
* Standard of Care
* Assignment of peer case manager
* Face-to-face meeting to tailor ICM approach to FSW preference
* Self-efficacy building in face-to-face sessions and bi-weekly text messages
* Relational support through monthly calls, face-to-face meetings every three months, and additional support through FSW initiated interaction
|
|---|---|---|
|
Viral Suppression of Retained
|
29.0 percentage of participants
Interval 22.9 to 35.1
|
23.0 percentage of participants
Interval 17.6 to 28.4
|
SECONDARY outcome
Timeframe: 18 months after study enrollmentPopulation: This outcome was analyzed by baseline randomization assignment (DTP vs. ICM). Groups included here reflect this.
Loss-to-follow-up across arms (DTP vs. ICM). This outcome is presented as an intention to treat analysis based on baseline randomization (DTP vs. ICM). All 777 participants randomized at baseline are included here. Loss to follow-up is defined as having missed the 18-month final study visit.
Outcome measures
| Measure |
Decentralized Treatment Provision (DTP) at Baseline
n=387 Participants
DTP:
* Standard of care, minus clinic referrals for ART treatment initiation and management.
* Nurse initiated and managed ART within the community on mobile van at sites served by the mobile van which already provides SoC services
|
Individualized Case Management (ICM) at Baseline
n=390 Participants
ICM:
* Standard of Care
* Assignment of peer case manager
* Face-to-face meeting to tailor ICM approach to FSW preference
* Self-efficacy building in face-to-face sessions and bi-weekly text messages
* Relational support through monthly calls, face-to-face meetings every three months, and additional support through FSW initiated interaction
|
|---|---|---|
|
Loss-to-Follow-Up
|
45.0 percentage of participants
Interval 40.0 to 49.9
|
41.3 percentage of participants
Interval 36.4 to 46.2
|
SECONDARY outcome
Timeframe: Acceptability of each intervention at 6 month timepointPopulation: This outcome was analyzed by baseline randomization status (DTP vs. ICM) which is reflected in the two groups included here. The number for analysis is smaller than the overall sample due to not all participants responding to acceptability questions either due to refusal or loss to follow up.
Participant reported intervention acceptability
Outcome measures
| Measure |
Decentralized Treatment Provision (DTP) at Baseline
n=176 Participants
DTP:
* Standard of care, minus clinic referrals for ART treatment initiation and management.
* Nurse initiated and managed ART within the community on mobile van at sites served by the mobile van which already provides SoC services
|
Individualized Case Management (ICM) at Baseline
n=189 Participants
ICM:
* Standard of Care
* Assignment of peer case manager
* Face-to-face meeting to tailor ICM approach to FSW preference
* Self-efficacy building in face-to-face sessions and bi-weekly text messages
* Relational support through monthly calls, face-to-face meetings every three months, and additional support through FSW initiated interaction
|
|---|---|---|
|
Intervention Acceptability
|
163 Participants
|
156 Participants
|
SECONDARY outcome
Timeframe: Up to 18 months after enrollmentPopulation: This outcome was analyzed by baseline randomization as reflected in the two groups included. The number analyzed reflects the number of individuals who were tested for drug resistance which was a subset of the sample in line with protocol guidelines.
Number of participants who were tested and identified as resistant to first line therapy and were referred to a Department of Health facility for second line therapy across arms
Outcome measures
| Measure |
Decentralized Treatment Provision (DTP) at Baseline
n=37 Participants
DTP:
* Standard of care, minus clinic referrals for ART treatment initiation and management.
* Nurse initiated and managed ART within the community on mobile van at sites served by the mobile van which already provides SoC services
|
Individualized Case Management (ICM) at Baseline
n=34 Participants
ICM:
* Standard of Care
* Assignment of peer case manager
* Face-to-face meeting to tailor ICM approach to FSW preference
* Self-efficacy building in face-to-face sessions and bi-weekly text messages
* Relational support through monthly calls, face-to-face meetings every three months, and additional support through FSW initiated interaction
|
|---|---|---|
|
2nd/3rd Line ART
|
36 Participants
|
32 Participants
|
SECONDARY outcome
Timeframe: Up to 18 months after enrollmentPopulation: This outcome was analyzed by baseline randomization assignment as shown in the two groups included here. The number of participants analyzed represents those tested for drug resistance in line with protocol guidelines.
Report and compare resistance across arms
Outcome measures
| Measure |
Decentralized Treatment Provision (DTP) at Baseline
n=42 Participants
DTP:
* Standard of care, minus clinic referrals for ART treatment initiation and management.
* Nurse initiated and managed ART within the community on mobile van at sites served by the mobile van which already provides SoC services
|
Individualized Case Management (ICM) at Baseline
n=35 Participants
ICM:
* Standard of Care
* Assignment of peer case manager
* Face-to-face meeting to tailor ICM approach to FSW preference
* Self-efficacy building in face-to-face sessions and bi-weekly text messages
* Relational support through monthly calls, face-to-face meetings every three months, and additional support through FSW initiated interaction
|
|---|---|---|
|
ART Resistance
|
37 Participants
|
34 Participants
|
SECONDARY outcome
Timeframe: Baseline, Follow-up up to 5 monthsPopulation: Participants with cost questionnaire data collected were included in analyses.
Participants' cost data were collected by opportunity cost questionnaire for the intervention arms in the trial and are summarized descriptively to support potential future modeling. Participants' costs are defined as costs associated with attending each visit for HIV care (transportation, food, child-care and other; and money that would have been earned from clients (opportunity cost). Follow-up costs were for attending each DTP/ICM and HIV care clinic visit.
Outcome measures
| Measure |
Decentralized Treatment Provision (DTP) at Baseline
n=183 Participants
DTP:
* Standard of care, minus clinic referrals for ART treatment initiation and management.
* Nurse initiated and managed ART within the community on mobile van at sites served by the mobile van which already provides SoC services
|
Individualized Case Management (ICM) at Baseline
n=176 Participants
ICM:
* Standard of Care
* Assignment of peer case manager
* Face-to-face meeting to tailor ICM approach to FSW preference
* Self-efficacy building in face-to-face sessions and bi-weekly text messages
* Relational support through monthly calls, face-to-face meetings every three months, and additional support through FSW initiated interaction
|
|---|---|---|
|
Participants' Costs South in African Rand (ZAR)
Baseline
|
186.8 ZAR
Interval 21.5 to 250.0
|
164.9 ZAR
Interval 12.0 to 233.0
|
|
Participants' Costs South in African Rand (ZAR)
Follow-up up to 5 months
|
127.7 ZAR
Interval 0.0 to 137.5
|
256.1 ZAR
Interval 34.3 to 361.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 18 months after enrollmentPopulation: Only a subset of participants received the DTP intervention either from baseline or at 6 months (550 total). The number of units represents the total expected number of DTP pickups per protocol.
Number and percentage of DTP pick-ups attended among participants randomized to received DTP.
Outcome measures
| Measure |
Decentralized Treatment Provision (DTP) at Baseline
n=8634 Total DTP pickups
DTP:
* Standard of care, minus clinic referrals for ART treatment initiation and management.
* Nurse initiated and managed ART within the community on mobile van at sites served by the mobile van which already provides SoC services
|
Individualized Case Management (ICM) at Baseline
ICM:
* Standard of Care
* Assignment of peer case manager
* Face-to-face meeting to tailor ICM approach to FSW preference
* Self-efficacy building in face-to-face sessions and bi-weekly text messages
* Relational support through monthly calls, face-to-face meetings every three months, and additional support through FSW initiated interaction
|
|---|---|---|
|
Decentralized Treatment Provision (DTP) Pick-Ups
|
3332 Total DTP pickups
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 18 months after enrollmentPopulation: Only a subset of participants received the ICM intervention, either from baseline or at 6 months (552 total). The units analyzed represent the total number of expected phone calls per protocol.
Number of ICM phone-based contacts
Outcome measures
| Measure |
Decentralized Treatment Provision (DTP) at Baseline
n=8640 Planned phone-based contacts
DTP:
* Standard of care, minus clinic referrals for ART treatment initiation and management.
* Nurse initiated and managed ART within the community on mobile van at sites served by the mobile van which already provides SoC services
|
Individualized Case Management (ICM) at Baseline
ICM:
* Standard of Care
* Assignment of peer case manager
* Face-to-face meeting to tailor ICM approach to FSW preference
* Self-efficacy building in face-to-face sessions and bi-weekly text messages
* Relational support through monthly calls, face-to-face meetings every three months, and additional support through FSW initiated interaction
|
|---|---|---|
|
ICM Phone-Based Contacts
|
593 Planned phone-based contacts
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 18 months after enrollmentPopulation: Only a subset of participants received the ICM intervention, either from baseline or at month 6 (552 total). The units analyzed represent the number of expected in person sessions per protocol.
Percentage of face-to-face case manager sessions attended
Outcome measures
| Measure |
Decentralized Treatment Provision (DTP) at Baseline
n=1273 Number of planned in-person ICM sessions
DTP:
* Standard of care, minus clinic referrals for ART treatment initiation and management.
* Nurse initiated and managed ART within the community on mobile van at sites served by the mobile van which already provides SoC services
|
Individualized Case Management (ICM) at Baseline
ICM:
* Standard of Care
* Assignment of peer case manager
* Face-to-face meeting to tailor ICM approach to FSW preference
* Self-efficacy building in face-to-face sessions and bi-weekly text messages
* Relational support through monthly calls, face-to-face meetings every three months, and additional support through FSW initiated interaction
|
|---|---|---|
|
ICM In-Person Meetings
|
392 Number of planned in-person ICM sessions
|
—
|
Adverse Events
Decentralize Treatment Provision (DTP) at Baseline
Serious events: 8 serious events
Other events: 0 other events
Deaths: 4 deaths
Individualized Case Management (ICM) at Baseline
Serious events: 16 serious events
Other events: 0 other events
Deaths: 12 deaths
Standard of Care (SoC) at Baseline
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
Enrolled But Not Randomized
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Decentralize Treatment Provision (DTP) at Baseline
n=387 participants at risk
DTP:
* Standard of care, minus clinic referrals for ART treatment initiation and management.
* Nurse initiated and managed ART within the community on mobile van at sites served by the mobile van which already provides SoC services
|
Individualized Case Management (ICM) at Baseline
n=390 participants at risk
ICM:
* Standard of Care
* Assignment of peer case manager
* Face-to-face meeting to tailor ICM approach to FSW preference
* Self-efficacy building in face-to-face sessions and bi-weekly text messages
* Relational support through monthly calls, face-to-face meetings every three months, and additional support through FSW initiated interaction
|
Standard of Care (SoC) at Baseline
n=523 participants at risk
SoC:
* HIV counseling and testing (HTC)
* STI screening and treatment
* TB screening and referral
* Health education through peer educators and peer supported follow-up related to linkages to care
* Referrals to DOH primary healthcare clinics or THC drop-in center for ART treatment initiation and management
Returns to SoC if virally suppressed at 6 months.
ICM: Peer-led ICM through quarterly face-to-face meetings, monthly phone calls and biweekly text messages.
|
Enrolled But Not Randomized
n=91 participants at risk
A subset of participants were enrolled in the study but not randomized for the following reasons:
* Missing viral loads (unknown viral suppression status)
* Unable to randomize due to losing contact after enrollment
* Mistakenly put in standard of care group (protocol violation)
* Withdrew from study
|
|---|---|---|---|---|
|
Social circumstances
Sexual violence
|
0.26%
1/387 • Number of events 1 • Up to 18 months
AEs were systematically investigated during lost to follow up tracing. Recent experiences of physical and sexual violence, hospitalizations were captured at study visits. All AEs were reported to the data safety \& monitoring board 6-monthly and institutional review board annually. None of the AEs, SAEs, or deaths reported were related to study involvement. AEs are reported by baseline randomization status in line with how they were systematically followed up on and documented by the two arms.
|
1.0%
4/390 • Number of events 4 • Up to 18 months
AEs were systematically investigated during lost to follow up tracing. Recent experiences of physical and sexual violence, hospitalizations were captured at study visits. All AEs were reported to the data safety \& monitoring board 6-monthly and institutional review board annually. None of the AEs, SAEs, or deaths reported were related to study involvement. AEs are reported by baseline randomization status in line with how they were systematically followed up on and documented by the two arms.
|
0.00%
0/523 • Up to 18 months
AEs were systematically investigated during lost to follow up tracing. Recent experiences of physical and sexual violence, hospitalizations were captured at study visits. All AEs were reported to the data safety \& monitoring board 6-monthly and institutional review board annually. None of the AEs, SAEs, or deaths reported were related to study involvement. AEs are reported by baseline randomization status in line with how they were systematically followed up on and documented by the two arms.
|
0.00%
0/91 • Up to 18 months
AEs were systematically investigated during lost to follow up tracing. Recent experiences of physical and sexual violence, hospitalizations were captured at study visits. All AEs were reported to the data safety \& monitoring board 6-monthly and institutional review board annually. None of the AEs, SAEs, or deaths reported were related to study involvement. AEs are reported by baseline randomization status in line with how they were systematically followed up on and documented by the two arms.
|
|
Social circumstances
Hospitalization
|
0.78%
3/387 • Number of events 3 • Up to 18 months
AEs were systematically investigated during lost to follow up tracing. Recent experiences of physical and sexual violence, hospitalizations were captured at study visits. All AEs were reported to the data safety \& monitoring board 6-monthly and institutional review board annually. None of the AEs, SAEs, or deaths reported were related to study involvement. AEs are reported by baseline randomization status in line with how they were systematically followed up on and documented by the two arms.
|
0.77%
3/390 • Number of events 3 • Up to 18 months
AEs were systematically investigated during lost to follow up tracing. Recent experiences of physical and sexual violence, hospitalizations were captured at study visits. All AEs were reported to the data safety \& monitoring board 6-monthly and institutional review board annually. None of the AEs, SAEs, or deaths reported were related to study involvement. AEs are reported by baseline randomization status in line with how they were systematically followed up on and documented by the two arms.
|
0.19%
1/523 • Number of events 1 • Up to 18 months
AEs were systematically investigated during lost to follow up tracing. Recent experiences of physical and sexual violence, hospitalizations were captured at study visits. All AEs were reported to the data safety \& monitoring board 6-monthly and institutional review board annually. None of the AEs, SAEs, or deaths reported were related to study involvement. AEs are reported by baseline randomization status in line with how they were systematically followed up on and documented by the two arms.
|
0.00%
0/91 • Up to 18 months
AEs were systematically investigated during lost to follow up tracing. Recent experiences of physical and sexual violence, hospitalizations were captured at study visits. All AEs were reported to the data safety \& monitoring board 6-monthly and institutional review board annually. None of the AEs, SAEs, or deaths reported were related to study involvement. AEs are reported by baseline randomization status in line with how they were systematically followed up on and documented by the two arms.
|
|
Social circumstances
Motor vehicle accident
|
0.00%
0/387 • Up to 18 months
AEs were systematically investigated during lost to follow up tracing. Recent experiences of physical and sexual violence, hospitalizations were captured at study visits. All AEs were reported to the data safety \& monitoring board 6-monthly and institutional review board annually. None of the AEs, SAEs, or deaths reported were related to study involvement. AEs are reported by baseline randomization status in line with how they were systematically followed up on and documented by the two arms.
|
0.26%
1/390 • Number of events 1 • Up to 18 months
AEs were systematically investigated during lost to follow up tracing. Recent experiences of physical and sexual violence, hospitalizations were captured at study visits. All AEs were reported to the data safety \& monitoring board 6-monthly and institutional review board annually. None of the AEs, SAEs, or deaths reported were related to study involvement. AEs are reported by baseline randomization status in line with how they were systematically followed up on and documented by the two arms.
|
0.00%
0/523 • Up to 18 months
AEs were systematically investigated during lost to follow up tracing. Recent experiences of physical and sexual violence, hospitalizations were captured at study visits. All AEs were reported to the data safety \& monitoring board 6-monthly and institutional review board annually. None of the AEs, SAEs, or deaths reported were related to study involvement. AEs are reported by baseline randomization status in line with how they were systematically followed up on and documented by the two arms.
|
0.00%
0/91 • Up to 18 months
AEs were systematically investigated during lost to follow up tracing. Recent experiences of physical and sexual violence, hospitalizations were captured at study visits. All AEs were reported to the data safety \& monitoring board 6-monthly and institutional review board annually. None of the AEs, SAEs, or deaths reported were related to study involvement. AEs are reported by baseline randomization status in line with how they were systematically followed up on and documented by the two arms.
|
|
Nervous system disorders
Stroke
|
0.00%
0/387 • Up to 18 months
AEs were systematically investigated during lost to follow up tracing. Recent experiences of physical and sexual violence, hospitalizations were captured at study visits. All AEs were reported to the data safety \& monitoring board 6-monthly and institutional review board annually. None of the AEs, SAEs, or deaths reported were related to study involvement. AEs are reported by baseline randomization status in line with how they were systematically followed up on and documented by the two arms.
|
0.26%
1/390 • Number of events 1 • Up to 18 months
AEs were systematically investigated during lost to follow up tracing. Recent experiences of physical and sexual violence, hospitalizations were captured at study visits. All AEs were reported to the data safety \& monitoring board 6-monthly and institutional review board annually. None of the AEs, SAEs, or deaths reported were related to study involvement. AEs are reported by baseline randomization status in line with how they were systematically followed up on and documented by the two arms.
|
0.00%
0/523 • Up to 18 months
AEs were systematically investigated during lost to follow up tracing. Recent experiences of physical and sexual violence, hospitalizations were captured at study visits. All AEs were reported to the data safety \& monitoring board 6-monthly and institutional review board annually. None of the AEs, SAEs, or deaths reported were related to study involvement. AEs are reported by baseline randomization status in line with how they were systematically followed up on and documented by the two arms.
|
0.00%
0/91 • Up to 18 months
AEs were systematically investigated during lost to follow up tracing. Recent experiences of physical and sexual violence, hospitalizations were captured at study visits. All AEs were reported to the data safety \& monitoring board 6-monthly and institutional review board annually. None of the AEs, SAEs, or deaths reported were related to study involvement. AEs are reported by baseline randomization status in line with how they were systematically followed up on and documented by the two arms.
|
|
Gastrointestinal disorders
Gallstones and swollen feet
|
0.00%
0/387 • Up to 18 months
AEs were systematically investigated during lost to follow up tracing. Recent experiences of physical and sexual violence, hospitalizations were captured at study visits. All AEs were reported to the data safety \& monitoring board 6-monthly and institutional review board annually. None of the AEs, SAEs, or deaths reported were related to study involvement. AEs are reported by baseline randomization status in line with how they were systematically followed up on and documented by the two arms.
|
0.26%
1/390 • Number of events 1 • Up to 18 months
AEs were systematically investigated during lost to follow up tracing. Recent experiences of physical and sexual violence, hospitalizations were captured at study visits. All AEs were reported to the data safety \& monitoring board 6-monthly and institutional review board annually. None of the AEs, SAEs, or deaths reported were related to study involvement. AEs are reported by baseline randomization status in line with how they were systematically followed up on and documented by the two arms.
|
0.00%
0/523 • Up to 18 months
AEs were systematically investigated during lost to follow up tracing. Recent experiences of physical and sexual violence, hospitalizations were captured at study visits. All AEs were reported to the data safety \& monitoring board 6-monthly and institutional review board annually. None of the AEs, SAEs, or deaths reported were related to study involvement. AEs are reported by baseline randomization status in line with how they were systematically followed up on and documented by the two arms.
|
0.00%
0/91 • Up to 18 months
AEs were systematically investigated during lost to follow up tracing. Recent experiences of physical and sexual violence, hospitalizations were captured at study visits. All AEs were reported to the data safety \& monitoring board 6-monthly and institutional review board annually. None of the AEs, SAEs, or deaths reported were related to study involvement. AEs are reported by baseline randomization status in line with how they were systematically followed up on and documented by the two arms.
|
|
Social circumstances
Imprisoned while enrolled in study
|
0.78%
3/387 • Number of events 3 • Up to 18 months
AEs were systematically investigated during lost to follow up tracing. Recent experiences of physical and sexual violence, hospitalizations were captured at study visits. All AEs were reported to the data safety \& monitoring board 6-monthly and institutional review board annually. None of the AEs, SAEs, or deaths reported were related to study involvement. AEs are reported by baseline randomization status in line with how they were systematically followed up on and documented by the two arms.
|
0.77%
3/390 • Number of events 3 • Up to 18 months
AEs were systematically investigated during lost to follow up tracing. Recent experiences of physical and sexual violence, hospitalizations were captured at study visits. All AEs were reported to the data safety \& monitoring board 6-monthly and institutional review board annually. None of the AEs, SAEs, or deaths reported were related to study involvement. AEs are reported by baseline randomization status in line with how they were systematically followed up on and documented by the two arms.
|
0.00%
0/523 • Up to 18 months
AEs were systematically investigated during lost to follow up tracing. Recent experiences of physical and sexual violence, hospitalizations were captured at study visits. All AEs were reported to the data safety \& monitoring board 6-monthly and institutional review board annually. None of the AEs, SAEs, or deaths reported were related to study involvement. AEs are reported by baseline randomization status in line with how they were systematically followed up on and documented by the two arms.
|
0.00%
0/91 • Up to 18 months
AEs were systematically investigated during lost to follow up tracing. Recent experiences of physical and sexual violence, hospitalizations were captured at study visits. All AEs were reported to the data safety \& monitoring board 6-monthly and institutional review board annually. None of the AEs, SAEs, or deaths reported were related to study involvement. AEs are reported by baseline randomization status in line with how they were systematically followed up on and documented by the two arms.
|
|
Social circumstances
Physical violence
|
0.26%
1/387 • Number of events 1 • Up to 18 months
AEs were systematically investigated during lost to follow up tracing. Recent experiences of physical and sexual violence, hospitalizations were captured at study visits. All AEs were reported to the data safety \& monitoring board 6-monthly and institutional review board annually. None of the AEs, SAEs, or deaths reported were related to study involvement. AEs are reported by baseline randomization status in line with how they were systematically followed up on and documented by the two arms.
|
0.77%
3/390 • Number of events 3 • Up to 18 months
AEs were systematically investigated during lost to follow up tracing. Recent experiences of physical and sexual violence, hospitalizations were captured at study visits. All AEs were reported to the data safety \& monitoring board 6-monthly and institutional review board annually. None of the AEs, SAEs, or deaths reported were related to study involvement. AEs are reported by baseline randomization status in line with how they were systematically followed up on and documented by the two arms.
|
0.00%
0/523 • Up to 18 months
AEs were systematically investigated during lost to follow up tracing. Recent experiences of physical and sexual violence, hospitalizations were captured at study visits. All AEs were reported to the data safety \& monitoring board 6-monthly and institutional review board annually. None of the AEs, SAEs, or deaths reported were related to study involvement. AEs are reported by baseline randomization status in line with how they were systematically followed up on and documented by the two arms.
|
0.00%
0/91 • Up to 18 months
AEs were systematically investigated during lost to follow up tracing. Recent experiences of physical and sexual violence, hospitalizations were captured at study visits. All AEs were reported to the data safety \& monitoring board 6-monthly and institutional review board annually. None of the AEs, SAEs, or deaths reported were related to study involvement. AEs are reported by baseline randomization status in line with how they were systematically followed up on and documented by the two arms.
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Stefan Baral
Johns Hopkins Bloomberg School of Public Health
Phone: 4105028975
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place