Discussion
viral suppression
DISEASE, RECRUITMENT, RECRUITMENT, SECONDARY
This RCT of a theory-based, mHealth intervention aimed to support viral suppression in women initiating or changing ART regimens. Despite efforts to extend the recruitment period and expand inclusion criteria to include women who did not report engagement in sex work, only 119 of the intended 210 women were enrolled, limiting our ability to detect significant findings. Recruitment was challenging because it was difficult to find a sufficient number of women who were HIV-seropositive, not currently taking ART, and willing to initiate treatment. In a setting where public-sector HIV treatment had been available since 2004 and treatment for all people living with HIV regardless of CD4 count or disease stage was implemented in 2016, this meant that most recruitment had to be achieved by identifying and enrolling FSW who were newly diagnosed with HIV into the Mombasa Cohort. We also recruited women who were switching to a second-line regimen due to treatment failure, but with modern ART regimens, these cases were infrequent. Of the 119 women who enrolled in the study, 69% of intervention and 63% of control participants were virally suppressed at six months. Participants in the intervention arm reported significantly higher adherence compared to participants in the control arm during the first month of the intervention.The small magnitude of the overall difference in viral suppression between the study arms may be related to the inclusion of an active control condition. Specifically, the standard of care included monthly appointments to monitor and support ART adherence and problem solve adherence barriers. Since both are evidence-based strategies for ART adherence [A secondary analysis was conducted to identify the intervention effect within the intended participant population. In addition to relaxing the inclusion criteria to include women who did not engage in sex work, 20% of the enrolled women denied taking ART, but had an undetectable viral load at baseline. Among women who reported engaging in sex work and who had a detectable viral load at baseline, viral load suppression was achieved by 74% of intervention participants compared to 46% of control participants.While mHealth interventions have demonstrated some efficacy for changing behavior, there are gaps in understanding the mechanisms through which these interventions effect change [Participants receiving In the decade since the initial 2-way text message intervention showed improvements in viral suppression [The qualitative data collected at the end of the study provided useful information about participant-level acceptability of the intervention and identified points for improvement. The content, number, and frequency of intervention text messages were generally well-received. The favorable feedback on acceptability may have extended from development of the intervention based on focus group discussions with the target population [This study had several notable strengths. First, it was the first intervention designed by and for FSW, a key population in the HIV epidemic. Second, validated tools were used to explore potential mechanisms influencing ART adherence and viral suppression. The LW-IMB-AAQ allowed a preliminary examination of the intervention’s effects on information, motivation, and behavioral skills [This study also had important limitations. First, the trial did not reach its target sample size, and the resulting analyses were under-powered to detect an intervention effect. Second, while the intervention was developed for FSW, inclusion criteria were relaxed to increase the number of evaluable participants. The intervention effect was larger in a subset analysis including only FSW, suggesting the potential for greater impact in the population for which the intervention was designed. Third, when viral load testing was performed after completion of the trial, 20% of participants were unexpectedly virally suppressed at enrollment. This suggests that some women who reported that they were just starting ART were already on treatment. Finally, while participants received sufficient paid airtime to return messages, several women reported that they ran out of airtime to respond. Future studies may benefit from providing free texting to the study number and utilization of community-owned wireless networks in Africa that provide free services to members.