18 and older, female only, with HIV-1 Virologic Response. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants Retained and Virally Suppressed Among Those Receiving the DTP Versus ICM ArmsPrimary· 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.
Group
Value
95% CI
Decentralized Treatment Provision (DTP) at Baseline
16.0
12.4 – 19.7
Individualized Case Management (ICM) at Baseline
14.1
10.6 – 17.6
Retention and Viral Suppression of Non-RespondersSecondary· 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
Group
Value
95% CI
Rerandomized to Continue DTP or ICM if Non-responsive
11.4
8.1 – 14.7
Rerandomized to Receive DTP+ICM if Non-responsive
11.3
7.9 – 14.7
Risk Factors of Loss to Follow-upSecondary· Up to 18 months after enrollment
Risk stratification to identify FSW at highest risk for loss to follow-up.
Steady partner, living together
Group
Value
95% CI
Lost to Follow-up
87
Not Lost to Follow-up (Retained in Care)
36
5 to 9 new clients in the past month
Group
Value
95% CI
Lost to Follow-up
159
Not Lost to Follow-up (Retained in Care)
40
Marijuana use in the past 30 days
Group
Value
95% CI
Lost to Follow-up
227
Not Lost to Follow-up (Retained in Care)
66
Experienced physical violence in the pasts 6 months
Group
Value
95% CI
Lost to Follow-up
338
Not Lost to Follow-up (Retained in Care)
103
Experienced sexual violence in the past 6 months
Group
Value
95% CI
Lost to Follow-up
250
Not Lost to Follow-up (Retained in Care)
73
Viral load of 50-1000 copies/mL at baseline
Group
Value
95% CI
Lost to Follow-up
130
Not Lost to Follow-up (Retained in Care)
54
Viral load greater than 1000 copies/mL at baseline
Group
Value
95% CI
Lost to Follow-up
448
Not Lost to Follow-up (Retained in Care)
145
Durability of Retention and Viral Suppression of RespondersSecondary· 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)
Group
Value
95% CI
DTP or ICM, Continue DTP or ICM if Responsive
43.1
29.5 – 56.7
DTP or ICM, Standard of Care (SoC) if Responsive
40.0
25.7 – 54.3
Adherence AssessmentSecondary· 18 months
Self-reported adherence to assess adherence across arms
Group
Value
95% CI
Decentralized Treatment Provision (DTP) at Baseline
46.5
39.6 – 53.4
Individualized Case Management (ICM) at Baseline
51.6
45.0 – 58.2
Viral Suppression of RetainedSecondary· Up to 18 months after enrollment
Among those retained, comparison of viral suppression across arms
Group
Value
95% CI
Decentralized Treatment Provision (DTP) at Baseline
29.0
22.9 – 35.1
Individualized Case Management (ICM) at Baseline
23.0
17.6 – 28.4
Loss-to-Follow-UpSecondary· 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.
Group
Value
95% CI
Decentralized Treatment Provision (DTP) at Baseline
45.0
40.0 – 49.9
Individualized Case Management (ICM) at Baseline
41.3
36.4 – 46.2
Intervention AcceptabilitySecondary· Acceptability of each intervention at 6 month timepoint
Participant reported intervention acceptability
Group
Value
95% CI
Decentralized Treatment Provision (DTP) at Baseline
163
Individualized Case Management (ICM) at Baseline
156
2nd/3rd Line ARTSecondary· 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
Group
Value
95% CI
Decentralized Treatment Provision (DTP) at Baseline
36
Individualized Case Management (ICM) at Baseline
32
ART ResistanceSecondary· Up to 18 months after enrollment
Report and compare resistance across arms
Group
Value
95% CI
Decentralized Treatment Provision (DTP) at Baseline
37
Individualized Case Management (ICM) at Baseline
34
Participants' Costs South in African Rand (ZAR)Secondary· 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.
Baseline
Group
Value
95% CI
Decentralized Treatment Provision (DTP)
186.8
21.5 – 250
Individualized Case Management (ICM)
164.9
12 – 233
Follow-up up to 5 months
Group
Value
95% CI
Decentralized Treatment Provision (DTP)
127.7
0 – 137.5
Individualized Case Management (ICM)
256.1
34.3 – 361.8
Decentralized Treatment Provision (DTP) Pick-UpsSecondary· Up to 18 months after enrollment
Number and percentage of DTP pick-ups attended among participants randomized to received DTP.
Group
Value
95% CI
Decentralized Treatment Provision (DTP) at Baseline and/or 6 Months
3332
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 18 months.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Decentralize Treatment Provision (DTP) at Baseline
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Johns Hopkins Bloomberg School of Public Health
Last refreshed: 14 January 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03500172.