Change Request

Proposed Changes in Data Collection Instruments for the “Greater Access and Impact with NAT (GAIN) Study: Improving HIV Diagnosis, Linkage to Care, and Prevention Services with HIV Point-of-Care Nucleic Acid Tests (NATs)” (OMB # 0920-1357)

Summary of changes and justification:

We are requesting a non-substantial change to the information collection for the GAIN Study. We propose to increase the stipend for additional surveys from $10 to $20 and for interviews from $40 to $80 for participants in the Madison Clinic Aim 3 of the study. We also propose to offer these amounts either as a gift card or cash.

We propose to increase the stipend amounts due to low enrollment in these portions of the study, despite recruitment among Madison Clinic Aim 3 participants and the surveys/interviews of these participants being our highest scientific priority. We are unclear on exactly why uptake has been low among these participants for the additional survey and interview, but as we enter our final year of funding, we plan to focus all our efforts on recruitment in this aim in order to achieve our scientific goals.

For the follow up interviews, only 19/51 (37.3%) participants have completed the follow up survey among Madison Clinic Aim 3 participants invited to do so. This is in contrast to 10/21 (47.6%) Madison Clinic Aim 1 participants and 132/198 (66.7%) Center Aim 1 participants, and 3/4 (75%) of Center Aim 3 participants.

Likewise, for the follow-up interviews, a total of 20 Aim 1 participants (from both sites) have completed an interview, enabling us to attain enough qualitative data for analysis. However, Aim 3 recruitment lags far behind, at a total of only 6 total Aim 3 interviews so far (5 from Madison Clinic, one from the Center). Due to funding constraints, we will not be able to continue enrollment of participants at the Center after August 2024, so we must focus entirely on the Aim 3 participants at Madison Clinic to achieve enrollment goals for this group. We hope that increasing the incentive will make participation more worthwhile for the participants’ time.

We also know that access to internet, computers, and phones can be a challenge for many of our Aim 3 participants at Madison Clinic, many of whom are unstably housed. This can make redemption of an online gift card challenging or impossible. We therefore also would like to have the option to reimburse participants in cash.