Trial Outcomes & Findings for Mobile Strategies for Women's and Children's Health: Optimizing Adherence and Efficacy of PMTCT/ART (NCT NCT02400671)

NCT ID: NCT02400671

Last Updated: 2022-11-02

Results Overview

Prevalence of virologic failure (HIV RNA ≥1000 c/ml) after the first 4 months post-ART will be compared between study arms using Generalized Estimating Equations (GEE) with log-binomial link.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 825 participants
• Primary outcome timeframe: 2 years postpartum
• Results posted on: 2022-11-02

Participant Flow

Between November 22, 2015 and May 4, 2017, participants were recruited from 6 public maternal child health (MCH) clinics in Kenya: 2 in peri-urban Nairobi County and 4 in rural Siaya, Kisumu, and Homa Bay Counties

825 participants were enrolled but it was later identified that one participant was enrolled twice. Only one of these records is included in analysis for a total participant number of 824

Participant milestones

Measure	Two-way SMS Participants will receive weekly push SMS messaging with a questions and have the ability to text back to the study nurse	One-Way SMS Participants will receive weekly push SMS messaging	Control Participants will receive standard of care (no intervention)
Overall Study STARTED	276	271	277
Overall Study COMPLETED	249	239	249
Overall Study NOT COMPLETED	27	32	28

Reasons for withdrawal

Measure	Two-way SMS Participants will receive weekly push SMS messaging with a questions and have the ability to text back to the study nurse	One-Way SMS Participants will receive weekly push SMS messaging	Control Participants will receive standard of care (no intervention)
Overall Study Death	5	3	4
Overall Study Lost to Follow-up	20	27	24
Overall Study Withdrawal by Subject	2	2	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Two-way SMS n=276 Participants Participants will receive weekly push SMS messaging with a questions and have the ability to text back to the study nurse SMS messaging	One-Way SMS n=271 Participants Participants will receive weekly push SMS messaging SMS messaging	Control n=277 Participants Participants will receive standard of care (no intervention)	Total n=824 Participants Total of all reporting groups
Age, Continuous	27 years n=276 Participants	28 years n=271 Participants	27 years n=277 Participants	27 years n=824 Participants
Sex: Female, Male Female	276 Participants n=276 Participants	271 Participants n=271 Participants	277 Participants n=277 Participants	824 Participants n=824 Participants
Sex: Female, Male Male	0 Participants n=276 Participants	0 Participants n=271 Participants	0 Participants n=277 Participants	0 Participants n=824 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Kenya	276 participants n=276 Participants	271 participants n=271 Participants	277 participants n=277 Participants	824 participants n=824 Participants
On antiretroviral therapy (ART) >=4 months	160 Participants n=276 Participants	161 Participants n=271 Participants	149 Participants n=277 Participants	470 Participants n=824 Participants
Viral load (VL) >=1000 at enrollment	88 Participants n=276 Participants	75 Participants n=271 Participants	81 Participants n=277 Participants	244 Participants n=824 Participants
Shares phone	81 Participants n=276 Participants	77 Participants n=271 Participants	87 Participants n=277 Participants	245 Participants n=824 Participants
Employed	133 Participants n=275 Participants • Missing responses	126 Participants n=271 Participants • Missing responses	159 Participants n=276 Participants • Missing responses	418 Participants n=822 Participants • Missing responses
Primigravida	49 Participants n=276 Participants	40 Participants n=271 Participants	26 Participants n=277 Participants	115 Participants n=824 Participants

PRIMARY outcome

Timeframe: 2 years postpartum

Population: Participants with VL data available \>=4 months post-ART initiation

Prevalence of virologic failure (HIV RNA ≥1000 c/ml) after the first 4 months post-ART will be compared between study arms using Generalized Estimating Equations (GEE) with log-binomial link.

Outcome measures

Measure	Two-way SMS n=1055 VL measurements Participants will receive weekly push SMS messaging with a questions and have the ability to text back to the study nurse	One-Way SMS n=1066 VL measurements Participants will receive weekly push SMS messaging	Control n=1029 VL measurements Participants will receive standard of care (no intervention)
Maternal Virologic Failure	90 VL measurements	119 VL measurements	99 VL measurements

PRIMARY outcome

Timeframe: Assessed at 24 months postpartum

Population: Participants with clinic visits scheduled during the study period

Timely clinic visit attendance during follow-up from enrollment in pregnancy to 12 and 24 months postpartum will be compared between study arms using GEE with log-binomial link.

Outcome measures

Measure	Two-way SMS n=4114 Scheduled visits Participants will receive weekly push SMS messaging with a questions and have the ability to text back to the study nurse	One-Way SMS n=4124 Scheduled visits Participants will receive weekly push SMS messaging	Control n=4199 Scheduled visits Participants will receive standard of care (no intervention)
Retention in Care	3664 Scheduled visits	3633 Scheduled visits	3709 Scheduled visits

PRIMARY outcome

Timeframe: Assessed at 24 months postpartum

Population: Participants still enrolled in the study at 24 months postpartum

The proportions of women lost to follow-up at 12 and 24 months postpartum will be compared between study arms by log-binomial regression.

Outcome measures

Measure	Two-way SMS n=267 Participants Participants will receive weekly push SMS messaging with a questions and have the ability to text back to the study nurse	One-Way SMS n=270 Participants Participants will receive weekly push SMS messaging	Control n=276 Participants Participants will receive standard of care (no intervention)
Loss to Follow-up	63 Participants	62 Participants	58 Participants

PRIMARY outcome

Timeframe: 2 years postpartum

Population: Participants with live-born infants

Incidence of infant HIV acquisition or death (events per person-time of follow-up) will be compared between study arms using Cox proportional hazards regression.

Outcome measures

Measure	Two-way SMS n=483 Person-years Participants will receive weekly push SMS messaging with a questions and have the ability to text back to the study nurse	One-Way SMS n=476 Person-years Participants will receive weekly push SMS messaging	Control n=502 Person-years Participants will receive standard of care (no intervention)
Infant HIV-free Survival	20 Events	11 Events	13 Events

SECONDARY outcome

Timeframe: 2 years postpartum

Population: Participants with pharmacy refill data available

ART adherence, defined as the proportion of days "covered" by ART between pharmacy refills, will be dichotomized and compared between arms using GEE with log-binomial link.

Outcome measures

Measure	Two-way SMS n=4108 Refill visits Participants will receive weekly push SMS messaging with a questions and have the ability to text back to the study nurse	One-Way SMS n=4096 Refill visits Participants will receive weekly push SMS messaging	Control n=4191 Refill visits Participants will receive standard of care (no intervention)
Maternal ART Adherence	2925 Refill visits	2881 Refill visits	2953 Refill visits

SECONDARY outcome

Timeframe: 2 years postpartum

Population: Participants without ART resistance at enrollment

Incidence of drug resistance on ART will be compared between study arms using Cox proportional hazards regression.

Outcome measures

Measure	Two-way SMS n=246 Participants Participants will receive weekly push SMS messaging with a questions and have the ability to text back to the study nurse	One-Way SMS n=248 Participants Participants will receive weekly push SMS messaging	Control n=254 Participants Participants will receive standard of care (no intervention)
Maternal ART Resistance	4 Participants	11 Participants	9 Participants

SECONDARY outcome

Timeframe: 2 years postpartum

Qualitative interviews at exit

Outcome measures

Outcome data not reported

Adverse Events

Two-way SMS

Serious events: 32 serious events

Other events: 15 other events

Deaths: 5 deaths

One-Way SMS

Serious events: 18 serious events

Other events: 17 other events

Deaths: 3 deaths

Control

Serious events: 24 serious events

Other events: 14 other events

Deaths: 4 deaths

Serious adverse events

Measure	Two-way SMS n=276 participants at risk Participants will receive weekly push SMS messaging with a questions and have the ability to text back to the study nurse	One-Way SMS n=271 participants at risk Participants will receive weekly push SMS messaging	Control n=277 participants at risk Participants will receive standard of care (no intervention)
Pregnancy, puerperium and perinatal conditions Maternal death	1.8% 5/276 • Pregnancy until 2 years postpartum visit (period of study enrollment)	1.1% 3/271 • Pregnancy until 2 years postpartum visit (period of study enrollment)	1.4% 4/277 • Pregnancy until 2 years postpartum visit (period of study enrollment)
Pregnancy, puerperium and perinatal conditions Infant death	5.8% 16/276 • Pregnancy until 2 years postpartum visit (period of study enrollment)	3.7% 10/271 • Pregnancy until 2 years postpartum visit (period of study enrollment)	4.7% 13/277 • Pregnancy until 2 years postpartum visit (period of study enrollment)
General disorders Maternal hospitalization	1.8% 5/276 • Pregnancy until 2 years postpartum visit (period of study enrollment)	0.37% 1/271 • Pregnancy until 2 years postpartum visit (period of study enrollment)	1.1% 3/277 • Pregnancy until 2 years postpartum visit (period of study enrollment)
General disorders Infant hospitalization	2.2% 6/276 • Pregnancy until 2 years postpartum visit (period of study enrollment)	1.5% 4/271 • Pregnancy until 2 years postpartum visit (period of study enrollment)	1.4% 4/277 • Pregnancy until 2 years postpartum visit (period of study enrollment)

Other adverse events

Measure	Two-way SMS n=276 participants at risk Participants will receive weekly push SMS messaging with a questions and have the ability to text back to the study nurse	One-Way SMS n=271 participants at risk Participants will receive weekly push SMS messaging	Control n=277 participants at risk Participants will receive standard of care (no intervention)
Pregnancy, puerperium and perinatal conditions Miscarriage/stillbirth	5.1% 14/276 • Pregnancy until 2 years postpartum visit (period of study enrollment)	5.5% 15/271 • Pregnancy until 2 years postpartum visit (period of study enrollment)	5.1% 14/277 • Pregnancy until 2 years postpartum visit (period of study enrollment)
Social circumstances Physical or sexual abuse	0.00% 0/276 • Pregnancy until 2 years postpartum visit (period of study enrollment)	0.74% 2/271 • Pregnancy until 2 years postpartum visit (period of study enrollment)	0.00% 0/277 • Pregnancy until 2 years postpartum visit (period of study enrollment)
Psychiatric disorders Psychological distress	0.36% 1/276 • Pregnancy until 2 years postpartum visit (period of study enrollment)	0.00% 0/271 • Pregnancy until 2 years postpartum visit (period of study enrollment)	0.00% 0/277 • Pregnancy until 2 years postpartum visit (period of study enrollment)

Additional Information

Dr. Keshet Ronen

University of Washington

Phone: 206-685-4363

Email: keshet@uw.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place