RNProtocolResearch in nursing & health2019

Siyaphambili protocol: An evaluation of randomized, nurse-led adaptive HIV treatment interventions for cisgender female sex workers living with HIV in Durban, South Africa.

Carly A Comins, Sheree R Schwartz, Deliwe R Phetlhu and 11 others

PMID 30644999

WHAT IT FOUND

No effectiveness results are reported.

Early enrollment data show most participants are on ART and about half are virally suppressed. The planned trial will compare nurse-led mobile ART delivery with peer case management. If viral suppression is not achieved, the plan escalates to both interventions.

Key findings

01The planned trial will randomize viremic cisgender female sex workers living with HIV to either mobile van ART delivery or peer case management. It will re-randomize them at six months based on viral suppression.

02The primary effectiveness outcome is retention in ART care plus viral suppression below 50 copies/ml at 18 months. The main comparison is between the two initially assigned interventions.

03Early enrollment data report that most participants are on ART and around half are virally suppressed. Of those enrolled, 88% own or have access to a cell phone.

STILL TO COME

How it was doneWhat they foundWhat it means for RNs

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What it does not show

This is a protocol. It describes planned methods and early enrollment observations, not tested intervention effects. The planned analysis will not directly compare the interventions with standard care. Laboratory viral load processing causes one to two-week delays in randomization and re-randomization. Integrating research into routine service delivery creates coordination challenges. The study says fidelity and implementation outcomes will be monitored. Participants must be viremic at enrollment, so the trial does not test these interventions for women already virally suppressed. Pregnant women are excluded, so safety and effectiveness in pregnancy are not assessed. The planned population is cisgender female sex workers in Durban receiving community HIV services. The results may not apply to other populations or health systems.

Declared interests

The supplied publication types list NIH extramural and non-U.S. government research support. The text gives no author conflict-of-interest declaration.

The easy way to misread this

Do not conclude that nurse-led mobile ART delivery or peer case management improves viral suppression. This is a protocol; the primary outcomes at 18 months have not been reported, and early enrollment data do not test the interventions.

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