Trial Outcomes & Findings for Evaluation of a mHealth Intervention to Increase Adherence to Triage of Self-collected HPV+ Women (ATICA Project) (NCT NCT03478397)

Last Updated: 2024-04-19

Results Overview

The percentage of women with triage Pap smears at 120 days after HPV results are registered in the national screening information system (SITAM). This will allow measurement of the overall effect of the multi-component intervention including two periods: a) the 60 day period between the Test results and the SMS message and e-mail sent to Community Health Workers (CHW) (days 1-59); and b) the 60 day period between the SMS message and e-mail sent to CHWs and triage measurement (days 60-120)

Recruitment status

COMPLETED

Study phase

Target enrollment

5389 participants

Primary outcome timeframe

120 days

Results posted on

2024-04-19

Participant Flow

Effectiveness trial women recruitment took place between December 4, 2018, and July 31, 2019. HPV self-collection is offered during the CHW routine home visits. During the visit, CHWs identified eligible women and invited them to participate.

All CHWs were assigned to the trial arms at the same time guaranteeing allocation concealment. Regarding women's consent, the CHWs were instructed to invite the woman and seek consent before disclosing their group allocation.

Participant milestones

Participant milestones
Measure	Multicomponent mHealth Intervention Women with HPV self-collected tests will receive a multicomponent intervention which includes SMS text messages to remind them to attend triage. In addition, CHWs will receive reminders via e-mails to contact women if after 60 days from the HPV-results HPV+ they have not performed triage. Multicomponent mHealth Intervention: Women with HPV self-collected tests will receive a multicomponent intervention which includes SMS text messages to remind them to attend triage. In addition, CHWs will receive reminders via e-mails to contact women if after 60 days from the HPV-results HPV+ they have not performed triage	Usual Care Women with HPV self-collected tests receive usual care. Upon opting for the HPV self-collected test, women will be instructed to go to the health care center in 30 days to pick up the results.
Overall Study STARTED	3272	2117
Overall Study Women Accepted to Participate	3241	2110
Overall Study COMPLETED	3241	2110
Overall Study NOT COMPLETED	31	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Multicomponent mHealth Intervention Women with HPV self-collected tests will receive a multicomponent intervention which includes SMS text messages to remind them to attend triage. In addition, CHWs will receive reminders via e-mails to contact women if after 60 days from the HPV-results HPV+ they have not performed triage. Multicomponent mHealth Intervention: Women with HPV self-collected tests will receive a multicomponent intervention which includes SMS text messages to remind them to attend triage. In addition, CHWs will receive reminders via e-mails to contact women if after 60 days from the HPV-results HPV+ they have not performed triage	Usual Care Women with HPV self-collected tests receive usual care. Upon opting for the HPV self-collected test, women will be instructed to go to the health care center in 30 days to pick up the results.
Overall Study Refused to participate	31	7

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Multicomponent mHealth Intervention n=445 Participants Women with HPV self-collected tests will receive a multicomponent intervention which includes SMS text messages to remind them to attend triage. In addition, CHWs will receive reminders via e-mails to contact women if after 60 days from the HPV-results HPV+ they have not performed triage. Multicomponent mHealth Intervention: Women with HPV self-collected tests will receive a multicomponent intervention which includes SMS text messages to remind them to attend triage. In addition, CHWs will receive reminders via e-mails to contact women if after 60 days from the HPV-results HPV+ they have not performed triage	Usual Care n=292 Participants Women with HPV self-collected tests receive usual care. Upon opting for the HPV self-collected test, women will be instructed to go to the health care center in 30 days to pick up the results.	Total n=737 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=445 Participants	0 Participants n=292 Participants	0 Participants n=737 Participants
Age, Categorical Between 18 and 65 years	445 Participants n=445 Participants	292 Participants n=292 Participants	737 Participants n=737 Participants
Age, Categorical >=65 years	0 Participants n=445 Participants	0 Participants n=292 Participants	0 Participants n=737 Participants
Sex: Female, Male Female	445 Participants n=445 Participants	292 Participants n=292 Participants	737 Participants n=737 Participants
Sex: Female, Male Male	0 Participants n=445 Participants	0 Participants n=292 Participants	0 Participants n=737 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Argentina	445 participants n=445 Participants	292 participants n=292 Participants	737 participants n=737 Participants
Triage Pap smear	0 Participants n=445 Participants	0 Participants n=292 Participants	0 Participants n=737 Participants

PRIMARY outcome

Timeframe: 120 days

Outcome measures

Outcome measures
Measure	Multicomponent mHealth Intervention n=445 Participants Women with HPV self-collected tests will receive a multicomponent intervention which includes SMS text messages to remind them to attend triage. In addition, CHWs will receive reminders via e-mails to contact women if after 60 days from the HPV-results HPV+ they have not performed triage. Multicomponent mHealth Intervention: Women with HPV self-collected tests will receive a multicomponent intervention which includes SMS text messages to remind them to attend triage. In addition, CHWs will receive reminders via e-mails to contact women if after 60 days from the HPV-results HPV+ they have not performed triage	Usual Care n=292 Participants Women with HPV self-collected tests receive usual care. Upon opting for the HPV self-collected test, women will be instructed to go to the health care center in 30 days to pick up the results.
Percentage of Women With Triage Pap Smears at 120 Days After HPV Results	314 Participants	163 Participants

SECONDARY outcome

Timeframe: 60 days

The percentage of women with triage Pap smears at 60 days after HPV results are registered in SITAM (days 1-59). This outcome will allow us to measure the individual effect of the SMS messages sent to women (before CHWs receive prompts to contact non compliant HPV+ women).

Outcome measures

Outcome measures
Measure	Multicomponent mHealth Intervention n=445 Participants Women with HPV self-collected tests will receive a multicomponent intervention which includes SMS text messages to remind them to attend triage. In addition, CHWs will receive reminders via e-mails to contact women if after 60 days from the HPV-results HPV+ they have not performed triage. Multicomponent mHealth Intervention: Women with HPV self-collected tests will receive a multicomponent intervention which includes SMS text messages to remind them to attend triage. In addition, CHWs will receive reminders via e-mails to contact women if after 60 days from the HPV-results HPV+ they have not performed triage	Usual Care n=292 Participants Women with HPV self-collected tests receive usual care. Upon opting for the HPV self-collected test, women will be instructed to go to the health care center in 30 days to pick up the results.
Percentage of Women With Triage Pap Smears at 60 Days After HPV Results	242 Participants	101 Participants

Adverse Events

Multicomponent mHealth Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Silvina Arrossi

CEDES

Phone: 541148651007

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place