HIV-1 Virologic Response
Conditions
Keywords
HIV, Female Sex Workers, Viral Suppression, South Africa, Decentralized care, Antiretroviral therapy, Differentiated care
Brief summary
The Siyaphambili Study is a sequential multistage adaptive randomized trial (SMART) to compare the effectiveness and durability of two behavioral interventions on the HIV-1 virologic response among female sex workers (FSW) living with HIV in Durban, South Africa. The interventions are: 1) nurse-led decentralized treatment program (DTP) and 2) individualized case management (ICM). Viral suppression is defined as a viral load assessment \<50 RNA copies/mL. The design will also estimate the incremental cost-effectiveness of study interventions and combinations of interventions compared with maintaining the South African standard of HIV care and treatment.
Detailed description
RATIONALE: Approximately 60% of the estimated 121,000 - 167,000 female sex workers (FSW) in South Africa are living with HIV. Research suggests only 39% of these women are currently on antiretroviral therapy (ART) and face individual, network and structural level barriers to ART initiation, retention and adherence. To prevent clinical treatment outcome disparities and reduce onward HIV transmission, understanding how best to adapt and implement, scalable and effective interventions to promote viral suppression among marginalized women is paramount. The overall goal of the Siyaphambili study is to inform South African HIV service delivery and scale up determining the most cost-effective package needed to achieve viral suppression among FSW and by characterizing the FSW most in need of these intensive HIV treatment interventions. HYPOTHESIS: DTP and ICM will be equally effective at achieving viral suppression and will have a synergistic effect when combined and targeted at those who remain non-responsive to either isolated intervention. Additionally, an adaptive, graduated multicomponent intervention to achieve viral suppression would be preferred under standard thresholds for cost-effectiveness over single-intensity interventions or intensive multicomponent interventions for all FSW. INTERVENTION: The Siyaphambili Study is a sequential multistage adaptive randomized trial (SMART) to compare the effectiveness and durability of two behavioral interventions on the HIV-1 virologic response among FSW living with HIV in Durban, South Africa. The interventions are: 1) nurse-led decentralized treatment program (DTP) and 2) individualized case management (ICM). The design will also estimate the incremental cost-effectiveness of study interventions and combinations of interventions compared with maintaining the South African standard of HIV care and treatment. STUDY DESIGN: A sequential multistage adaptive randomized study, embedded within the TB/HIV Care program in Durban, South Africa, will enroll 800 viremic FSW into the 18-month trial. Women will be randomized to either DTP or ICM at enrolment and rerandomized 6 months after enrolment based on their response to the initial intervention. PRIMARY OBJECTIVE: To compare the effectiveness and durability of nurse-led DTP and ICM in isolation or in combination to achieve viral suppression. SECONDARY OBJECTIVE: To estimate the incremental impact and cost-effectiveness associated with study interventions and combination of interventions. OUTCOMES: The primary outcome of the study is retention and viral suppression among those initially randomized to the DTP verse ICM intervention. The secondary outcomes are retention and viral suppression of non-responders, retention and viral suppression among month 6 non-responders, retention and viral suppression at 18 months among month 6 non-responders randomized to continuation of either intervention verse combined DTP+ICM, risk stratification tool, durability of retention and viral suppression of responders, to assess adherence, to assess viral suppression of retained, loss-to-follow-up, intervention acceptability, switching to 2nd/3rd line ART, and ART resistance. ANALYTIC PLAN: Primary analysis for primary outcome: Retention in ART care and viral suppression will be a combined outcome in an intention to treat (ITT) analysis at 18 months to compare participants initially randomized to the DTP verse ICM intervention. Viral suppression is defined as a viral load assessment \<50 RNA copies/mL and participants lost to follow up or who experience death during the trial duration will be grouped with non-virally suppressed participants.
Interventions
BEHAVIORALDTP
Provision of antiretroviral therapy (ART) in the community through a mobile-van DTP managed by a nurse capable of initiating and managing ART.
BEHAVIORALICM
Peer-led ICM through quarterly face-to-face meetings, monthly phone calls and biweekly text messages.
Sponsors
University of the Western Cape
TB HIV Care
University of Toronto
University of California, San Francisco
National Institute for Communicable Diseases, South Africa
Johns Hopkins Bloomberg School of Public Health
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This sequential multistage adaptive randomized trial (SMART) assesses two interventions to address treatment barriers: (1) nurse-led mobile decentralized treatment programs (DTP) and (2) peer-led, individualized case management (ICM).
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Sells sex for goods or money as their main source of income 2. Assigned female sex at birth 3. ≥ 18 years of age 4. Living with HIV; diagnosed ≥ 6 months prior 5. Currently living in Durban 6. If on ART, initiated ≥2 months prior
Exclusion criteria
1. Engagement in an ongoing HIV treatment research study 2. Planning on leaving Durban for more than 3 months in the following 12 months 3. Pregnant at time of enrollment 4. On a second line or third ART regimen 5. Participating in an adherence club
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Retained and Virally Suppressed Among Those Receiving the DTP Versus ICM Arms | 18 months after enrollment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Viral Suppression of Retained | Up to 18 months after enrollment | Among those retained, comparison of viral suppression across arms |
| 2nd/3rd Line ART | Up to 18 months after enrollment | 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 |
| ART Resistance | Up to 18 months after enrollment | Report and compare resistance across arms |
| Participants' Costs South in African Rand (ZAR) | Baseline, Follow-up up to 5 months | 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. |
| Retention and Viral Suppression of Non-Responders | 18 months after enrollment | Retention and viral suppression at 18 months among month 6 non-responders randomized to continuation of either intervention vs. combined DTP+ICM |
| Risk Factors of Loss to Follow-up | Up to 18 months after enrollment | Risk stratification to identify FSW at highest risk for loss to follow-up. |
| Durability of Retention and Viral Suppression of Responders | Up to 18 months after enrollment | 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) |
| Adherence Assessment | 18 months | Self-reported adherence to assess adherence across arms |
| Loss-to-Follow-Up | 18 months after study enrollment | 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. |
| Intervention Acceptability | Acceptability of each intervention at 6 month timepoint | Participant reported intervention acceptability |
Other
| Measure | Time frame | Description |
|---|---|---|
| ICM In-Person Meetings | Up to 18 months after enrollment | Percentage of face-to-face case manager sessions attended |
| Decentralized Treatment Provision (DTP) Pick-Ups | Up to 18 months after enrollment | Number and percentage of DTP pick-ups attended among participants randomized to received DTP. |
| ICM Phone-Based Contacts | Up to 18 months after enrollment | Number of ICM phone-based contacts |
Countries
South Africa
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 390 |
| Decentralized Treatment Provision (DTP) at Baseline 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 | 387 |
| Standard of Care (Virally Suppressed at Baseline OR Lost to Follow up Before Baseline Randomization) 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 | 614 |
| Total | 1,391 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Death | 0 | 0 | 0 | 4 | 2 | 0 | 5 | 2 | 0 | 0 | 0 |
| Period 2: Re-Randomization | Lost to Follow-up | 8 | 6 | 87 | 68 | 4 | 6 | 63 | 74 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Decentralized Treatment Provision (DTP) at Baseline | Individualized Case Management (ICM) at Baseline | Total | Standard of Care (Virally Suppressed at Baseline OR Lost to Follow up Before Baseline Randomization) |
|---|---|---|---|---|
| Advertises service online | 10 Participants | 15 Participants | 54 Participants | 29 Participants |
| Age, Customized Age 18-24 | 64 Participants | 60 Participants | 202 Participants | 78 Participants |
| Age, Customized Age 25-29 | 123 Participants | 135 Participants | 377 Participants | 119 Participants |
| Age, Customized Age 30-35 | 117 Participants | 113 Participants | 402 Participants | 172 Participants |
| Age, Customized Age 35+ | 82 Participants | 82 Participants | 404 Participants | 240 Participants |
| Age, Customized Age Missing | 1 Participants | 0 Participants | 6 Participants | 5 Participants |
| Always carries condoms while working | 333 Participants | 341 Participants | 1203 Participants | 529 Participants |
| Antiretroviral therapy experience ART Naive | 72 Participants | 70 Participants | 179 Participants | 37 Participants |
| Antiretroviral therapy experience Ever Initiated | 315 Participants | 320 Participants | 1208 Participants | 573 Participants |
| Antiretroviral therapy experience Missing | 0 Participants | 0 Participants | 4 Participants | 4 Participants |
| Baseline viral load 50 to 1000 copies/mL (non-virally suppressed) | 87 Participants | 96 Participants | 211 Participants | 28 Participants |
| Baseline viral load Greater than 1000 copies/mL (non-virally suppressed) | 300 Participants | 294 Participants | 646 Participants | 52 Participants |
| Baseline viral load Less than 50 copies/mL (virally suppressed) | 0 Participants | 0 Participants | 523 Participants | 523 Participants |
| Baseline viral load Missing | 0 Participants | 0 Participants | 11 Participants | 11 Participants |
| Can read and/or write in Zulu or English | 379 Participants | 382 Participants | 1346 Participants | 585 Participants |
| Consistent condom use with new clients (last 30 days) Consistent | 226 Participants | 223 Participants | 820 Participants | 371 Participants |
| Consistent condom use with new clients (last 30 days) Did not have sex with a new client in last 30 days | 8 Participants | 12 Participants | 38 Participants | 18 Participants |
| Consistent condom use with new clients (last 30 days) Inconsistent | 146 Participants | 145 Participants | 501 Participants | 210 Participants |
| Consistent condom use with new clients (last 30 days) Refusal/missing | 7 Participants | 10 Participants | 32 Participants | 15 Participants |
| Consistent condom use with non-paying partners (last 30 days) Consistent | 37 Participants | 55 Participants | 169 Participants | 77 Participants |
| Consistent condom use with non-paying partners (last 30 days) Inconsistent | 165 Participants | 138 Participants | 559 Participants | 256 Participants |
| Consistent condom use with non-paying partners (last 30 days) No sex with non-paying partner in past 30 days | 182 Participants | 190 Participants | 636 Participants | 264 Participants |
| Consistent condom use with non-paying partners (last 30 days) Refusal/missing | 3 Participants | 7 Participants | 27 Participants | 17 Participants |
| Consistent condom use with regular clients (last 30 days) Consistent | 186 Participants | 183 Participants | 681 Participants | 312 Participants |
| Consistent condom use with regular clients (last 30 days) Did not have sex with a regular client in the last 30 days | 20 Participants | 17 Participants | 62 Participants | 25 Participants |
| Consistent condom use with regular clients (last 30 days) Inconsistent | 174 Participants | 179 Participants | 613 Participants | 260 Participants |
| Consistent condom use with regular clients (last 30 days) Refusal/missing | 7 Participants | 11 Participants | 35 Participants | 17 Participants |
| Current employment other than sex work Missing | 1 Participants | 3 Participants | 14 Participants | 10 Participants |
| Current employment other than sex work None | 366 Participants | 371 Participants | 1298 Participants | 561 Participants |
| Current employment other than sex work Private or public employed | 3 Participants | 2 Participants | 15 Participants | 10 Participants |
| Current employment other than sex work Refusal | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Current employment other than sex work Self-employed (formal or informal) | 16 Participants | 14 Participants | 63 Participants | 33 Participants |
| Currently enrolled in school Currently enrolled in school | 1 Participants | 2 Participants | 12 Participants | 9 Participants |
| Currently enrolled in school Not currently enrolled in school | 386 Participants | 388 Participants | 1379 Participants | 605 Participants |
| Depression Mild depression | 176 Participants | 178 Participants | 641 Participants | 287 Participants |
| Depression Missing | 5 Participants | 5 Participants | 30 Participants | 20 Participants |
| Depression Moderate depression | 52 Participants | 47 Participants | 188 Participants | 89 Participants |
| Depression Moderately severe depression | 54 Participants | 72 Participants | 193 Participants | 67 Participants |
| Depression No/minimal depression | 78 Participants | 66 Participants | 258 Participants | 114 Participants |
| Depression Severe depression | 22 Participants | 22 Participants | 81 Participants | 37 Participants |
| Drinks alcohol two or more times a week | 163 Participants | 165 Participants | 568 Participants | 240 Participants |
| Education Any post-secondary education or technical training | 7 Participants | 18 Participants | 44 Participants | 19 Participants |
| Education Complete/incomplete primary education | 28 Participants | 29 Participants | 136 Participants | 79 Participants |
| Education Missing | 1 Participants | 2 Participants | 12 Participants | 9 Participants |
| Education Never attended | 6 Participants | 4 Participants | 25 Participants | 15 Participants |
| Education Secondary school complete | 67 Participants | 54 Participants | 219 Participants | 98 Participants |
| Education Secondary school incomplete | 278 Participants | 283 Participants | 955 Participants | 394 Participants |
| Ever experienced physical abuse | 215 Participants | 231 Participants | 743 Participants | 297 Participants |
| Ever experienced sexual abuse | 166 Participants | 159 Participants | 517 Participants | 192 Participants |
| Ever injected drugs | 21 Participants | 23 Participants | 57 Participants | 13 Participants |
| Hormonal contraception | 119 Participants | 130 Participants | 485 Participants | 236 Participants |
| Hospitalized in last 6 months | 40 Participants | 40 Participants | 156 Participants | 76 Participants |
| Median age at first exchange of sex acts for goods | 22 years | 22 years | 22 years | 23 years |
| Median age at first exchange of sex acts for money | 22 years | 22 years | 23 years | 23 years |
| Median age at first sex | 17 years | 16 years | 17 years | 17 years |
| Median self-reported health state | 51 units on a scale | 51 units on a scale | 52 units on a scale | 56 units on a scale |
| Nationality Other (Incl. Lesotho, Eswatini, Zimbabwe, Botswana) | 7 Participants | 11 Participants | 37 Participants | 19 Participants |
| Nationality South African | 380 Participants | 379 Participants | 1354 Participants | 595 Participants |
| Non-hormonal contraception | 377 Participants | 378 Participants | 1343 Participants | 588 Participants |
| Parity Missing | 1 Participants | 0 Participants | 3 Participants | 2 Participants |
| Parity Nulliparous/No live births | 83 Participants | 90 Participants | 278 Participants | 105 Participants |
| Parity One live birth | 136 Participants | 136 Participants | 454 Participants | 182 Participants |
| Parity Three or more live births | 81 Participants | 68 Participants | 332 Participants | 183 Participants |
| Parity Two live births | 86 Participants | 96 Participants | 324 Participants | 142 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 0 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 372 Participants | 375 Participants | 1341 Participants | 594 Participants |
| Race (NIH/OMB) More than one race | 12 Participants | 13 Participants | 35 Participants | 10 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 12 Participants | 9 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment South Africa | 387 Participants | 390 Participants | 1391 Participants | 614 Participants |
| Relationship status Missing | 1 Participants | 2 Participants | 12 Participants | 9 Participants |
| Relationship status Single | 188 Participants | 213 Participants | 699 Participants | 298 Participants |
| Relationship status Steady partner, living together | 64 Participants | 59 Participants | 209 Participants | 86 Participants |
| Relationship status Steady partner, not living together | 134 Participants | 116 Participants | 471 Participants | 221 Participants |
| Sex: Female, Male Female | 387 Participants | 390 Participants | 1391 Participants | 614 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Tested for tuberculosis in last 6 months | 227 Participants | 224 Participants | 825 Participants | 374 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 4 / 387 | 12 / 390 | 1 / 523 | 0 / 91 |
| other Total, other adverse events | 0 / 387 | 0 / 390 | 0 / 523 | 0 / 91 |
| serious Total, serious adverse events | 8 / 387 | 16 / 390 | 1 / 523 | 0 / 91 |
Outcome results
Primary
Percentage of Participants Retained and Virally Suppressed Among Those Receiving the DTP Versus ICM Arms
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.
Time frame: 18 months after enrollment
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Decentralized Treatment Provision (DTP) at Baseline | Percentage of Participants Retained and Virally Suppressed Among Those Receiving the DTP Versus ICM Arms | 16.0 percentage of participants |
| Individualized Case Management (ICM) at Baseline | Percentage of Participants Retained and Virally Suppressed Among Those Receiving the DTP Versus ICM Arms | 14.1 percentage of participants |
p-value: 0.455Two sample test of proportions
Secondary
2nd/3rd Line ART
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
Time frame: Up to 18 months after enrollment
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Decentralized Treatment Provision (DTP) at Baseline | 2nd/3rd Line ART | 36 Participants |
| Individualized Case Management (ICM) at Baseline | 2nd/3rd Line ART | 32 Participants |
Secondary
Adherence Assessment
Self-reported adherence to assess adherence across arms
Time frame: 18 months
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Decentralized Treatment Provision (DTP) at Baseline | Adherence Assessment | 46.5 percentage of participants |
| Individualized Case Management (ICM) at Baseline | Adherence Assessment | 51.6 percentage of participants |
p-value: 0.295Two sample test of proportions
Secondary
ART Resistance
Report and compare resistance across arms
Time frame: Up to 18 months after enrollment
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Decentralized Treatment Provision (DTP) at Baseline | ART Resistance | 37 Participants |
| Individualized Case Management (ICM) at Baseline | ART Resistance | 34 Participants |
p-value: 0.212Chi-squared
Secondary
Durability of Retention and Viral Suppression of Responders
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)
Time frame: Up to 18 months after enrollment
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Decentralized Treatment Provision (DTP) at Baseline | Durability of Retention and Viral Suppression of Responders | 43.1 percentage of participants |
| Individualized Case Management (ICM) at Baseline | Durability of Retention and Viral Suppression of Responders | 40.0 percentage of participants |
p-value: 0.756Two sample test of proportions
Secondary
Intervention Acceptability
Participant reported intervention acceptability
Time frame: Acceptability of each intervention at 6 month timepoint
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Decentralized Treatment Provision (DTP) at Baseline | Intervention Acceptability | 163 Participants |
| Individualized Case Management (ICM) at Baseline | Intervention Acceptability | 156 Participants |
Secondary
Loss-to-Follow-Up
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.
Time frame: 18 months after study enrollment
Population: This outcome was analyzed by baseline randomization assignment (DTP vs. ICM). Groups included here reflect this.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Decentralized Treatment Provision (DTP) at Baseline | Loss-to-Follow-Up | 45.0 percentage of participants |
| Individualized Case Management (ICM) at Baseline | Loss-to-Follow-Up | 41.3 percentage of participants |
p-value: 0.301Two sample test of proportions
Secondary
Participants' Costs South in African Rand (ZAR)
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.
Time frame: Baseline, Follow-up up to 5 months
Population: Participants with cost questionnaire data collected were included in analyses.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Decentralized Treatment Provision (DTP) at Baseline | Participants' Costs South in African Rand (ZAR) | Baseline | 186.8 ZAR |
| Decentralized Treatment Provision (DTP) at Baseline | Participants' Costs South in African Rand (ZAR) | Follow-up up to 5 months | 127.7 ZAR |
| Individualized Case Management (ICM) at Baseline | Participants' Costs South in African Rand (ZAR) | Baseline | 164.9 ZAR |
| Individualized Case Management (ICM) at Baseline | Participants' Costs South in African Rand (ZAR) | Follow-up up to 5 months | 256.1 ZAR |
Secondary
Retention and Viral Suppression of Non-Responders
Retention and viral suppression at 18 months among month 6 non-responders randomized to continuation of either intervention vs. combined DTP+ICM
Time frame: 18 months after enrollment
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Decentralized Treatment Provision (DTP) at Baseline | Retention and Viral Suppression of Non-Responders | 11.4 percentage of participants |
| Individualized Case Management (ICM) at Baseline | Retention and Viral Suppression of Non-Responders | 11.3 percentage of participants |
p-value: 0.962Two sample test of proportions
Secondary
Risk Factors of Loss to Follow-up
Risk stratification to identify FSW at highest risk for loss to follow-up.
Time frame: Up to 18 months after enrollment
Population: Risk factors for loss to follow up were analyzed across the sample, not by randomization assignment. Groups here reflect this approach.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Decentralized Treatment Provision (DTP) at Baseline | Risk Factors of Loss to Follow-up | Marijuana use in the past 30 days | 227 Participants |
| Decentralized Treatment Provision (DTP) at Baseline | Risk Factors of Loss to Follow-up | Experienced sexual violence in the past 6 months | 250 Participants |
| Decentralized Treatment Provision (DTP) at Baseline | Risk Factors of Loss to Follow-up | 5 to 9 new clients in the past month | 159 Participants |
| Decentralized Treatment Provision (DTP) at Baseline | Risk Factors of Loss to Follow-up | Viral load of 50-1000 copies/mL at baseline | 130 Participants |
| Decentralized Treatment Provision (DTP) at Baseline | Risk Factors of Loss to Follow-up | Experienced physical violence in the pasts 6 months | 338 Participants |
| Decentralized Treatment Provision (DTP) at Baseline | Risk Factors of Loss to Follow-up | Viral load greater than 1000 copies/mL at baseline | 448 Participants |
| Decentralized Treatment Provision (DTP) at Baseline | Risk Factors of Loss to Follow-up | Steady partner, living together | 87 Participants |
| Individualized Case Management (ICM) at Baseline | Risk Factors of Loss to Follow-up | Viral load greater than 1000 copies/mL at baseline | 145 Participants |
| Individualized Case Management (ICM) at Baseline | Risk Factors of Loss to Follow-up | Steady partner, living together | 36 Participants |
| Individualized Case Management (ICM) at Baseline | Risk Factors of Loss to Follow-up | 5 to 9 new clients in the past month | 40 Participants |
| Individualized Case Management (ICM) at Baseline | Risk Factors of Loss to Follow-up | Marijuana use in the past 30 days | 66 Participants |
| Individualized Case Management (ICM) at Baseline | Risk Factors of Loss to Follow-up | Experienced physical violence in the pasts 6 months | 103 Participants |
| Individualized Case Management (ICM) at Baseline | Risk Factors of Loss to Follow-up | Experienced sexual violence in the past 6 months | 73 Participants |
| Individualized Case Management (ICM) at Baseline | Risk Factors of Loss to Follow-up | Viral load of 50-1000 copies/mL at baseline | 54 Participants |
Comparison: Statistical test for risk of LTFU for steady partner, living together vs. single.p-value: <0.0595% CI: [0.61, 0.99]Regression, Cox
Comparison: Statistical test for risk of LTFU for 5-9 new clients in the past month vs. 0 clients in the past month.p-value: <0.0595% CI: [1.02, 2.51]Regression, Cox
Comparison: Statistical test for risk of LTFU for use of marijuana in the past 30 days vs. no marijuana use in the past 30 daysp-value: <0.0595% CI: [1.09, 1.57]Regression, Cox
Comparison: Statistical test for risk of LTFU among those experiencing physical violence in the past 6 months vs. no experience of physical violence in the past 6 months.p-value: <0.0595% CI: [1.01, 1.52]Regression, Cox
Comparison: Statistical test for risk of LTFU among those who have experienced sexual violence in the past 6 months vs. those who have notp-value: <0.0595% CI: [1.31, 2]Regression, Cox
Comparison: Statistical test for risk of LTFU among those with viral loads from 50-1000 copies/mL at baseline vs. \<50 copies/mL.p-value: <0.0595% CI: [1.65, 3.29]Regression, Cox
Comparison: Statistical test for risk of LTFU among those with viral load greater than 1000 copies/mL vs. those with viral load less than 50 copies/mL.p-value: <0.0595% CI: [1.82, 3.36]Regression, Cox
Secondary
Viral Suppression of Retained
Among those retained, comparison of viral suppression across arms
Time frame: Up to 18 months after enrollment
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Decentralized Treatment Provision (DTP) at Baseline | Viral Suppression of Retained | 29.0 percentage of participants |
| Individualized Case Management (ICM) at Baseline | Viral Suppression of Retained | 23.0 percentage of participants |
p-value: 0.149Two sample test of proportions
Other Pre-specified
Decentralized Treatment Provision (DTP) Pick-Ups
Number and percentage of DTP pick-ups attended among participants randomized to received DTP.
Time frame: Up to 18 months after enrollment
Population: 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.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Decentralized Treatment Provision (DTP) at Baseline | Decentralized Treatment Provision (DTP) Pick-Ups | 3332 Total DTP pickups |
Other Pre-specified
ICM In-Person Meetings
Percentage of face-to-face case manager sessions attended
Time frame: Up to 18 months after enrollment
Population: 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.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Decentralized Treatment Provision (DTP) at Baseline | ICM In-Person Meetings | 392 Number of planned in-person ICM sessions |
Other Pre-specified
ICM Phone-Based Contacts
Number of ICM phone-based contacts
Time frame: Up to 18 months after enrollment
Population: 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.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Decentralized Treatment Provision (DTP) at Baseline | ICM Phone-Based Contacts | 593 Planned phone-based contacts |