Uptake of antiretroviral therapy and male circumcision after community-based HIV testing and strategies for linkage to care versus standard clinic referral: a multisite, open-label, randomised controlled trial in South Africa and Uganda.
Male circumcision decreases HIV acquisition by 60%, and antiretroviral therapy (ART) almost eliminates HIV transmission from HIV-positive people who are virally suppressed; however, coverage of these interventions has lagged behind targets. We aimed to assess whether community-based HIV testing with counsellor support and point-of-care CD4 cell count testing would increase uptake of ART and male circumcision.
We did this multisite, open-label, randomised controlled trial in six research-naive communities in rural South Africa and Uganda. Eligible HIV-positive participants (aged ≥16 years) were randomly assigned (1:1:1) in a factorial design to receive lay counsellor clinic linkage facilitation, lay counsellor follow-up home visits, or standard-of-care clinic referral, and then (1:1) either point-of-care CD4 cell count testing or referral for CD4 testing. HIV-negative uncircumcised men (aged 16-49 years) who could receive secure mobile phone text messages were randomly assigned (1:1:1) to receive text message reminders, lay counsellor visits, or standard clinic referral. The study biostatistician generated the randomisation schedule via a computer-generated random number program with varying block sizes (multiples of six or three) stratified by country. Primary outcomes for HIV-positive people were obtaining a CD4 cell count, linkage to an HIV clinic, ART initiation, and viral suppression at 9 months, and for HIV-negative uncircumcised men were visiting a circumcision facility and uptake of male circumcision at 3 months. We assessed social harms as a safety outcome throughout the study. We did the primary analyses by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT02038582.
Between June 6, 2013, and March 11, 2015, 15 332 participants were tested. 2339 (15%) participants tested HIV positive, of whom 1325 (57%) were randomly assigned to receive lay counsellor clinic linkage facilitation (n=437), lay counsellor follow-up home visits (n=449), or standard clinic referral (n=439), and then point-of-care CD4 cell testing (n=206, n=220, and n=213, respectively) or referral for CD4 testing (n=231, n=229, and n=226, respectively). 12 993 (85%) participants tested HIV negative, of whom 750 (6%) uncircumcised men were randomly assigned to receive clinic referral (n=230), text message reminders (n=288), or lay counsellor follow-up visits (n=232). 1218 (93%) of 1303 HIV-positive participants were linked to care, but only 488 (37%) participants initiated ART. Overall, 635 (50%) of 1272 HIV-positive individuals achieved viral suppression at 9 months: 219 (52%) of 419 participants in the clinic facilitation group, 202 (47%) of 431 participants in the lay counsellor follow-up group, and 214 (51%) of 422 participants in the clinic referral group, with no significant differences between groups (p=0·668 for clinic facilitation and p=0·273 for lay counsellor follow-up vs clinic referral). 523 (72%) of 734 HIV-negative men visited a circumcision facility, with no difference between groups. 62 (28%) of 224 men were circumcised in the male circumcision clinic referral group compared with 137 (48%) of 284 men in the text message reminder group (relative risk 1·72, 95% CI 1·36-2·17; p<0·0001) and 106 (47%) of 226 men in the lay counsellor follow-up group (1·67, 1·29-2·14; p=0·0001). No cases of study-related social harm were reported, including probing about partnership separation, unintended disclosure, gender-based violence, and stigma.
All the community-based strategies achieved high rates of linkage of HIV-positive people to HIV clinics, roughly a third of whom initiated ART, and of those more than 80% were virally suppressed at 9 months. Uptake of male circumcision was almost two-times higher in men who received text message reminders or lay counsellor visits than in those who received standard-of-care clinic referral. Clinic barriers to ART initiation should be addressed in future strategies to increase the proportion of HIV-positive people accessing treatment and achieving viral suppression.
National Institute of Allergy and Infectious Diseases, National Institutes of Health.
Barnabas RV
，van Rooyen H
，Tumwesigye E
，Brantley J
，Baeten JM
，van Heerden A
，Turyamureeba B
，Joseph P
，Krows M
，Thomas KK
，Schaafsma TT
，Hughes JP
，Celum C
... -
《Lancet HIV》
The Implementation of a Text Messaging Intervention to Improve HIV Continuum of Care Outcomes Among Persons Recently Released From Correctional Facilities: Randomized Controlled Trial.
Previously incarcerated individuals have suboptimal linkage and engagement in community HIV care. Mobile health (mHealth) interventions have been shown to be effective in addressing these gaps. In Washington, District of Columbia (DC), we conducted a randomized trial of an SMS text messaging-based mHealth intervention (CARE+ Corrections) to increase linkage to community HIV care and antiretroviral treatment adherence among HIV-infected persons involved in the criminal justice system.
This study aimed to describe the SMS text messaging-based intervention, participant use of the intervention, and barriers and facilitators of implementation.
From August 2013 to April 2015, HIV-positive incarcerated individuals were recruited within the DC Department of Corrections, and persons released in the past 6 months were recruited within the community via street-based recruitment, community partnerships, and referrals. Participants were followed for 6 months and received weekly or daily SMS text messages. Formative research resulted in the development of the content of the messages in 4 categories: HIV Appointment Reminders, Medication Adherence, Prevention Reminders, and Barriers to Care following release from jail. Participants could customize the timing, frequency, and message content throughout the study period.
Of the 112 participants enrolled, 57 (50.9%) were randomized to the intervention group and 55 (49.1%) to the control group; 2 control participants did not complete the baseline visit, and were dropped from the study, leaving a total of 110 participants who contributed to the analyses. Study retention was similar across both study arms. Median age was 42 years (IQR 30-50), 86% (49/57) were black or African American, 58% (33/57) were male, 25% (14/57) were female, and 18% (10/57) were transgender. Median length of last incarceration was 4 months (IQR 1.7-9.0), and median lifetime number of times incarcerated was 6.5 (IQR 3.5-14.0). Most participants (32/54, 59%) had a baseline viral load of <200 copies/mL. Nearly all participants (52/57, 91%) chose to use a cell phone provided by the study. The most preferred Appointment Reminder message was Hey how you feeling? Don't forget to give a call and make your appointment (19/57, 33%). The most preferred Medication Adherence message was Don't forget your skittles! (31/57, 54%), and 63% (36/57) of participants chose to receive daily (vs weekly) messages from this category at baseline. The most preferred Prevention Reminder message was Stay strong. Stay clean (18/57, 32%). The most preferred Barriers to Care message was Holla at your case manager, they're here to help (12/57, 22%). Minor message preference differences were observed among participants enrolled in the jail versus those from the community.
Participants' ability to customize their SMS text message plan proved helpful. Further large-scale research on mHealth platforms is needed to assess its efficacy among HIV-infected persons with a history of incarceration.
ClinicalTrials.gov NCT01721226; https://clinicaltrials.gov/ct2/show/NCT01721226.
Uhrig Castonguay BJ
，Cressman AE
，Kuo I
，Patrick R
，Trezza C
，Cates A
，Olsen H
，Peterson J
，Kurth A
，Bazerman LB
，Beckwith CG
... -
《JMIR mHealth and uHealth》
ResearchGate
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